News

Responsible AI in Life Sciences: PLG and ETHIQAIS Collaboration

Fabiana Nichetti — Wed, 08 Apr 2026 04:00:00 GMT

Paris, March 2026 — ProductLife Group (PLG) announces a strategic collaboration with ETHIQAIS, a company specialized in AI risks governance and compliance, to further strengthen the deployment of responsible, secure and regulation-ready artificial intelligence solutions across highly regulated industries.

In life sciences, the adoption of AI is no longer only a matter of technological innovation. It requires robust governance frameworks ensuring traceability, risk control and full alignment with evolving regulatory requirements, including the European AI Act.

This collaboration comes at a pivotal moment, as European authorities continue to structure AI governance frameworks, reinforcing the need for compliant, transparent and controlled AI deployment.

Recent regulatory developments are accelerating the transition from high-level principles to enforceable requirements, with measures such as the designation of national authorities — including CNIL — to oversee AI governance.

For organizations operating in regulated environments, this means that AI governance is no longer optional, it is becoming a core component of operational and compliance strategies.

As part of this initiative, PLG has leveraged the ETHIQAIS platform and expertise to assess and structure the governance of its AI solutions, enabling centralized oversight, risk classification and alignment with regulatory expectations.

The assessment confirmed a high level of maturity in governance, risk management and operational control across PLG’s AI solutions, aligned with the requirements of the European AI regulatory framework. This is particularly impactful, as these AI solutions have been developed internally at PLG, leveraging the latest Large Language Models and agentic AI technologies.

Beyond internal validation, this initiative also strengthens ProductLife Group’s ability to support clients in structuring, deploying and scaling AI solutions that are compliant with evolving regulatory frameworks. By combining regulatory expertise with digital and operational capabilities, PLG enables life sciences organizations to move from experimentation to controlled, production-ready AI use.
This is particularly critical as companies seek to unlock the value of AI while ensuring full traceability, auditability and risk control
— key requirements in GxP and other regulated environments.

“At ProductLife Group, we see AI as a strategic enabler for the life sciences industry, but only if it is deployed with the right level of governance and control. This collaboration reinforces our commitment to delivering AI solutions that are both innovative and compliant by design.”
— Søren Winkel, Head of Digital BU, ProductLife Group

“Bridging innovation and compliance is one of the key challenges for AI in regulated environments. This initiative demonstrates how structured governance and robust methodologies can turn regulatory constraints into a framework for sustainable innovation.”
— Gabrièle Piaton, Head of Research & Innovation, ProductLife Group

For ProductLife Group, this collaboration confirms a core conviction: advanced AI and regulatory compliance are not opposing forces, but complementary drivers of sustainable innovation.

“The evaluation of ProductLife Group’s AI solutions highlighted a strong level of maturity in governance and risk management, fully aligned with the expectations of the European AI Act. We are proud to support PLG in this journey.”
— Alina Holcroft, CEO, ETHIQAIS

This initiative reflects a broader commitment from both organizations to support companies in deploying AI solutions that are not only innovative, but also secure, compliant and fully operational in regulated environments.

ProductLife Group’s Science-Based Targets Validated by SBTi

Fabiana Nichetti — Mon, 26 Jan 2026 05:00:00 GMT

The validation of ProductLife Group’s near-term science-based greenhouse gas (GHG) emission reduction targets by the Science Based Targets initiative (SBTi) marks an important milestone in the Group’s sustainability and corporate responsibility journey.

In a context where climate-related considerations are increasingly critical for organisations operating across global value chains , science-based targets provide a structured and internationally recognised framework to address greenhouse gas emissions in a consistent and transparent manner. For ProductLife Group, this validation confirms that its near-term climate targets meet SBTi criteria and are aligned with a 1.5°C climate trajectory .

As a global Life Sciences consulting and services group , PLG recognises the importance of integrating climate considerations into business practices and decision-making .

This commitment is reflected in the definition of clear, measurable, and science-based targets across its operations and value chain, which are outlined below.

Scope 1 & 2 ProductLife Group commits to reduce absolute scope 1 and 2 GHG emissions by 50.4% by 2032, from a 2024 base year.

Scope 3 – Economic Intensity Target ProductLife Group commits to reduce scope 3 GHG emissions from fuel- and energy-related activities, waste generated in operations, business travel, employee commuting and upstream leased assets by 58.14% per EUR value added by 2032, from a 2024 base year.

Scope 3 – Supplier Engagement Target ProductLife Group commits that 67.0% of its suppliers by spend, covering purchased goods and services and capital goods, will have science-based targets by 2030.

These validated targets provide a clear, science-based framework to guide PLG’s decarbonization efforts over time. They help prioritize action, strengthen collaboration with suppliers, and help embed climate-related considerations into organizational decision-making.

For ProductLife Group, this target validation is not an endpoint, but a key step forward. It reinforces the group's commitment to responsible business practices, long-term resilience, continuous improvement, and forms part of a broader sustainability and CSR approach aimed at supporting sustainable value creation across our ecosystem. ProductLife Group’s validated near-term science-based targets, as published on the SBTi Target Dashboard.

About the SBTi

The Science Based Targets initiative (SBTi) is a global body enabling businesses to set ambitious emissions reduction targets in line with the latest climate science. It is focused on accelerating companies across the world to halve emissions before 2030 and achieve net-zero emissions before 2050.

The initiative is a collaboration between CDP, the United Nations Global Compact (UNGC), World Resources Institute (WRI) and the World Wide Fund for Nature (WWF) and is one among the We Mean Business Coalition commitments. It defines and promotes best practices in science-based target-setting, offers resources and guidance to reduce barriers to adoption, and independently assesses and approves companies’ climate targets.

Introducing PL Africa – PLG’s New Regional Hub

Fabiana Nichetti — Mon, 01 Dec 2025 05:00:00 GMT

As part of ProductLife Group’s continuous expansion and commitment to supporting Life Sciences organisations worldwide, PL Morocco and PL Tunisia are now joining forces under a unified identity:
ProductLife Africa – a ProductLife Group company.

This strategic evolution marks an important milestone in PLG’s regional development. By bringing together two established hubs, PL Africa reinforces our long-standing dedication to supporting pharmaceutical and healthcare stakeholders across a continent experiencing rapid growth, regulatory transformation, and increasing investment in local manufacturing.

A reinforced regional hub for Life Sciences organisations

Africa is emerging as a dynamic market for innovation, healthcare access, and regulatory modernisation. As national authorities introduce new frameworks and local supply capabilities expand, Life Sciences companies require partners able to combine global expertise with local regulatory insight .
PL Africa has been designed precisely to address this need.

What this integration means for our clients and partners

Regionalised services powered by local experts Our combined teams in Morocco and Tunisia bring an in-depth understanding of national regulations, submission pathways, and compliance expectations.

Stronger collaboration between our hubs The unified structure enables smoother coordination, shared capabilities, and consistent delivery standards across the region.

Seamless support aligned with global PLG quality Clients benefit from the full strength of PLG’s global network and methodologies, adapted to local requirements and market realities.

Supporting Africa’s Life Sciences transformation

Regulatory harmonisation initiatives, investment in biopharmaceutical production, and the rise of digital health solutions are all shaping a rapidly evolving ecosystem. With PL Africa, ProductLife Group reaffirms its role as a trusted partner for companies looking to grow in this environment.
PL Africa embodies our commitment to enabling scientific progress, regulatory compliance, and sustainable value creation throughout the continent.
From regulatory submissions and PV operations to quality and compliance support, our teams stand ready to assist organisations navigating Africa’s changing healthcare landscape.

Stay connected with PL Africa

Follow our updates to discover regulatory insights , success stories , and market perspectives from across the region.
To learn more about how PL Africa can support your projects, contact our experts via the form here

AI in Life Sciences: PLG Insights at PLG Morocco

Giulia Maffei — Tue, 14 Oct 2025 04:00:00 GMT

On 18 September 2025 , ProductLife Group (PLG) inaugurated its new regional office in Casablanca , marking a major milestone in the Group’s One Africa strategy and reinforcing its commitment to innovation, knowledge sharing, and collaboration across the African Life Sciences ecosystem.

To celebrate this step forward, PLG hosted a panel discussion on “The Role of Artificial Intelligence in Transforming the Life Sciences Industry” , featuring: Xavier Duburcq , CEO, Jean-Luc Taborin , EVP & Head of Strategic Consulting together with Mohamed El Bouhmadi , President of the Moroccan Federation of the Pharmaceutical and Innovation Industry (FMIIP) and CEO of Zenith Pharma , and Omar Sefiani , Co-Founder and CEO of Sobrus .

Moderated by Jean-Luc Taborin, the panel explored how AI is redefining the way medicines are developed, manufactured, and delivered to patients , and how strategic collaboration between global and local stakeholders can accelerate innovation in healthcare systems.

AI as an engine for transformation across the value chain

The conversation underscored a key message: Artificial Intelligence is reshaping the entire Life Sciences value chain , from R&D and regulatory affairs to manufacturing and pharmacovigilance.

AI’s capacity to process and connect vast, heterogeneous datasets is accelerating drug discovery, clinical design, and safety monitoring , creating a systemic understanding of complex diseases and reducing development timelines by several months.

Yet, the impact of AI extends far beyond R&D. It is now transforming how companies manage compliance, quality, and operational excellence , helping to streamline documentation, regulatory submissions, and risk monitoring.

Artificial Intelligence brings together science and technology, enabling faster, smarter, and more connected innovation across the Life Sciences industry.

It is not only about efficiency, it is about redefining how we design, deliver, and sustain healthcare solutions globally.

From vision to implementation: a structured approach

As the discussion revealed, unlocking AI’s potential requires a strategic and structured approach . PLG presented its own methodology, built around design thinking and value-driven analysis , to help organizations identify the most relevant use cases for AI adoption.

This includes evaluating:

the strategic fit with company objectives,

the operational value and return on investment,

the data accessibility and privacy safeguards,

the technological feasibility, and

the ethical and regulatory compliance frameworks that govern AI in healthcare.

True transformation requires more than deploying new tools. It means designing the right use cases, aligning data and governance, and managing change across people, systems, and culture.

PLG’s experience has shown that AI can reduce manual workloads by up to 90% in data extraction and regulatory document authoring , while improving quality and consistency. In pharmacovigilance, AI-driven automation has the potential to cut case processing time by half, allowing professionals to focus on scientific interpretation and patient safety.

Building an ecosystem of innovation

The panel also emphasized the importance of collaboration between industry, regulators, technology providers, and service companies . Morocco, with its dynamic pharmaceutical sector and growing investment in digital health, was highlighted as a strategic hub for innovation in Africa - one where PLG aims to bridge global expertise and local talent.

The future of AI in Life Sciences will depend on strong partnerships that combine scientific knowledge, regulatory insight, and technological innovation - building a collective journey toward responsible and sustainable transformation.

Shaping the future of AI at ProductLife Group

As PLG expands its footprint across Africa and globally, digital transformation and Artificial Intelligence remain at the core of its mission : to help life sciences companies accelerate innovation, ensure compliance, and improve patient access to safe and effective therapies.

Following this event, PLG will publish its white paper “The Transformative Power of AI in Shaping the Pharmaceutical Industry” , featuring results from its global survey and practical use cases developed by its Consulting and Digital teams .

The combination of business, technology, innovation, and consultancy is what maximizes the value of digitalization.

AI is not just a tool, it is a driver for collaboration and transformation across the entire product lifecycle.

ProductLife Group publishes its 2024 Sustainability Report

Giulia Maffei — Tue, 14 Oct 2025 04:00:00 GMT

ProductLife Group (PLG) has released its 2024 Sustainability Report, reaffirming its commitment to responsible growth, ethical governance, and sustainable innovation across the Life Sciences industry.

The report highlights the progress achieved over the past year in key Environmental, Social, and Governance (ESG) areas, in alignment with the United Nations Global Compact principles and the Sustainable Development Goals (SDGs).

Sustainability is embedded in how PLG operates every day. It is not a parallel initiative but a core business pillar - essential to the company’s success in quality, compliance, and innovation.

PLG has built a global organization that drives positive impact for patients, partners, and the planet, and this report illustrates how these ambitions are being translated into tangible actions.

From commitment to concrete results

In 2024, PLG reached several milestones that demonstrate measurable progress and accountability:

58% of management positions held by women, confirming PLG’s dedication to diversity, equity, and inclusion.
12 countries certified as Great Place to Work, recognizing a culture rooted in collaboration, respect, and well-being.
Launch of a global whistleblower system, ensuring transparency and ethical conduct across all operations.
Integration of CSR criteria into supplier due diligence, promoting sustainable procurement and responsible sourcing.
Commitment to the Science Based Targets initiative (SBTi), aligning PLG’s climate action strategy with the 1.5°C global pathway.

In recognition of its progress, PLG was awarded the EcoVadis Gold Medal in October 2025, placing the company among the top 5% of rated organizations worldwide for sustainability performance.

This achievement reflects the strong foundation built through PLG’s 2024 initiatives and reinforces our ongoing commitment to building an inclusive, ethical, and forward-looking organization.

Empowering people, shaping a sustainable future

The report also highlights the role of people engagement in PLG’s sustainability journey. Through initiatives such as the PLG Social Ambassadors program, CSR Week, Wellness Week, and Zero Plastic Week, employees across five continents actively contribute to environmental, social, and ethical initiatives that foster inclusion and shared purpose.

We are proud of what has been achieved — but we know that sustainability is an ongoing journey. Our goal is to keep improving, ensuring that our growth continues to benefit our employees, our clients, and society at large.

Looking ahead

Building on these achievements, PLG will continue to strengthen its ESG performance through measurable actions:

Submitting near-term emissions reduction targets for validation under the Science Based Targets initiative (SBTi).
Expanding sustainable procurement and supplier training.
Pursuing ISO 27001 certification to reinforce information security and data ethics.

PLG’s 2024 Sustainability Report reflects a clear direction: a global organization determined to grow responsibly, inspire change, and drive sustainable impact in Life Sciences.

PLG France earns EcoVadis Gold Medal in sustainability milestone

Giulia Maffei — Thu, 09 Oct 2025 04:00:00 GMT

Why EcoVadis matters

In an era where sustainability is no longer optional but essential, third-party validation becomes a critical differentiator. EcoVadis is the global standard for corporate sustainability ratings, assessing companies across four core dimensions: Environment, Labour & Human Rights, Ethics, and Sustainable Procurement.

The EcoVadis rating is based on detailed questionnaires, supporting documentation, and expert third-party review. Its scorecard provides a transparent benchmark allowing companies and their stakeholders to track performance, compare peers, and identify areas for continuous improvement.

The medals (Bronze → Silver → Gold → Platinum) represent increasing levels of performance and maturity.

Today, we are proud to announce that PLG France has been awarded the Gold Medal, placing us in the top 5% of all rated companies.

Our journey: from Silver to Gold - what changed

Achieving Gold did not happen overnight; it reflects a concerted effort across policy, governance, and execution at group level.

Here are the key drivers behind the upgrade:

Stronger group-level policy frameworks, including the PLG Environment Policy, Labour & Human Rights Policy, CSR Governance Policy, and Sustainable Procurement Policy

Implementation of a new & improved whistleblower system, and a reinforced ethics & anti-corruption code of practice

More rigorous carbon accounting, with external audit and deeper granularity in emissions measurement

Adoption of a Green IT strategy to reduce the digital footprint of our operations

Commitment to employee wellbeing, career development, flexibility, inclusion, and robust health & safety practices

Validation through external certifications and alignment with global frameworks: Great Place to Work certification, UN Global Compact Communication on Progress, among others

Together, these initiatives ensure that sustainability is not just a label but integrated into our operations, governance, and culture.

Impact across PLG’s footprint: affiliates & collective strength

One of the strengths of our group model is that this recognition extends beyond a single entity. Within PLG’s perimeters, six other affiliates are also rated by EcoVadis, with varying medals from Bronze to Gold - Pharma IT, Intexo, LifeBee, Commercial Eyes, Intiquan, Pharma D&S.

This collective presence underscores our intention to elevate sustainability across the organization, not just at a single office.

Shared learning, cross-affiliate benchmarking, and coordinated ESG initiatives help lift the whole group's performance.

What this means for our stakeholders & next steps

For clients, partners, and employees, this Gold Medal is a commitment — a signal that PLG is investing in long-term resilience, responsible growth, and trustworthy business practices.

Going forward, our focus is on:

Continuous improvement — leveraging the EcoVadis scorecard and feedback to address gaps

Deepening data governance and ESG reporting

Rolling out training and change programs to ensure our teams across all affiliates live these standards

Encouraging our supplier network to elevate their sustainability practices, in line with our procurement expectations

Communication and transparency, turning this recognition into a pivot point for broader stakeholder engagement

A milestone, not a finish line

The Gold Medal from EcoVadis is a proud moment - but it’s not the destination. It’s evidence that when governance, strategy, and action align, recognition follows.

Sustainability is woven into our future: in how we operate, how we grow, and how we partner. This accolade strengthens our resolve to lead by example - and to help others on their journey.

Thank you to all colleagues, teams, and partners who contributed to this achievement.
Let’s keep pushing forward, together!

Contact us

PLG Expands into Japan: The World’s #3 Largest Pharma Market

Giulia Maffei — Thu, 18 Sep 2025 04:00:00 GMT

ProductLife Group Expands into Japan: Strengthening Global Reach with Local Expertise

On September 4 ^th, 2025, ProductLife Group announced the opening of its newest office in Tokyo, Japan, a major step forward in its journey of global expansion.

This step reinforces PLG’s commitment to serving clients in the world’s most critical life sciences markets, offering solutions that combine global expertise with local insights.

“Expanding into new global markets is not just a growth strategy—it’s a commitment to accelerating the development of life-changing drugs and devices,” said PLG. “By broadening our reach, we’re able to bring innovative solutions to more patients, faster, and deliver on our promise to improve health outcomes worldwide.”

Why Japan? A Strategic Hub for Life Sciences

Japan is not only the third-largest pharmaceutical market in the world, valued at around USD 82–86 billion in 2024, but also a global innovation hub. While overall market growth is projected to remain moderate (CAGR ~2.5% to 2033), segments such as biologics, patented therapies, and biotechnology are expanding rapidly.

The biotechnology market alone — including gene therapies, regenerative medicine, and advanced diagnostics — is expected to grow from USD 23.9 billion in 2024 to nearly USD 39 billion by 2035.

Several factors make Japan a cornerstone for PLG’s strategy:

Market opportunity: Patented and innovative drugs are forecast to reach ¥11 trillion (~USD 70 billion) by 2027, representing a high-value growth segment.
Demographic demand: With 29% of the population aged over 65 and 16% over 75, Japan faces unprecedented healthcare needs. In 2022, total medical expenditure reached ~USD 306.5 billion, with more than 40% spent on patients over 75.
Innovation hub: Japan has a strong R&D infrastructure, world-class universities, and government incentives for biotech and digital health. This makes the country a leader in regenerative medicine, cell and gene therapies, and diagnostics.
Regulatory support: Recent reforms by the Pharmaceuticals and Medical Devices Agency (PMDA) have streamlined approval timelines and expanded the use of real-world data in clinical and regulatory decision-making. Combined with the universal National Health Insurance (NHI) system, these measures create both opportunities and accelerated access for innovative therapies.

Together, these conditions create fertile ground for PLG to deliver its expertise and support life sciences companies in bringing new solutions to patients.

PLG's ambition in the Region

Tanya van der Wall, Managing Director, JAPAC, will play a pivotal role in shaping PLG’s success in Japan. Reflecting on this milestone, she said: “It is fantastic to now be able to support our global clients across our service areas for such an important global market as Japan. Whether companies already have a presence in Japan, or are looking to enter, local expertise is critical to navigating this complex environment. We are asked all the time if we have local experts on the ground in Japan — and we are now very pleased to be able to say yes!”

Tanya emphasized that PLG Japan will initially focus on safety & vigilance entrustment services and regulatory affairs, while progressively expanding to cover the full range of PLG’s services, including digital transformation projects. She noted: “Our immediate priority is to build a strong, locally rooted team that embodies PLG’s values while meeting the demand of our clients in Japan. These services are only the beginning — our goal is to establish PLG Japan as a trusted partner providing comprehensive support across the product lifecycle.”

She also reflected on the unique challenges of the Japanese life sciences market, pointing to its dual-agency regulatory system (PMDA and MHLW), strict language requirements, and unique approval pathways that often require local clinical data. Frequent regulatory changes, a centralized pricing system with biennial revisions, and a strong post-market safety framework add further complexity. Tanya explained: “Success in this market requires a Japan-specific strategy, strong local partnerships, and continuous adaptation to evolving regulatory and reimbursement settings. Having local, experienced professionals who know how to navigate these processes is critical — and this is exactly the value PLG Japan brings to our clients.”

Collaboration, she stressed, is another cornerstone: “Our Tokyo office is already working closely with colleagues from Commercial Eyes in Australia and PLG teams worldwide on multi-market safety & vigilance programs. This spirit of collaboration will be key to helping clients from the US, Europe, and beyond successfully enter and grow in Japan.

Looking ahead, Tanya summarized the significance of this opening in one word: “Milestone.” She added: “This year we have navigated the legal, regulatory, quality, and business environment to establish the company and meet strict requirements. Collaborating with local partners to help overcome language and cultural barriers has been challenging but also rewarding and working with our Japanese colleagues is a real pleasure. There is still plenty to do, learn, build, and achieve — but we are excited for the future.”

Looking Ahead

With its expansion into Japan, ProductLife Group strengthens its role as a global strategic partner for life sciences companies, supporting them throughout the product lifecycle, from regulatory approvals and market access, to safety & vigilance and compliance

Japan’s sophisticated healthcare environment offers immense opportunities locally while also serving as a gateway for innovation and global validation.

By combining local expertise with its worldwide network, PLG is well-positioned to help clients navigate complexity, seize opportunities, and deliver life-changing solutions to patients.

Learn more about PLG Japan

Contact us

ProductLife Group Opens Regional Hub in Casablanca, Morocco

Giulia Maffei — Wed, 17 Sep 2025 04:00:00 GMT

Casablanca, 18 September 2025 – ProductLife Group (PLG), a global consulting and outsourcing partner for the life sciences industry, has inaugurated its new regional office in Casablanca. This strategic launch positions Morocco as the Group’s African hub, marking a milestone in its One Africa initiative.

The event gathered around 60 participants, including PLG representatives — among them Xavier Duburcq, CEO, and Jean-Luc Taborin, EVP Head of Consulting — as well as key figures of the Moroccan and international pharmaceutical and digital ecosystem, such as Mohamed El Bouhmadi, President of FMIIP, and Omar Sefiani, CEO of Sobrus.

At the heart of the inauguration, a high-level panel explored “The key role of Artificial Intelligence in transforming the life sciences industry”, moderated by Jean-Luc Taborin and drawing on PLG’s white paper “An Introduction to the Transformative Power of AI in Shaping the Pharmaceutical Industry”.

Xavier Duburcq, CEO of PLG, stated: “By establishing PL Morocco, we reinforce our presence in Africa and create a hub where local expertise meets international experience. Artificial Intelligence is a powerful lever to accelerate innovation, improve access to care, and optimize health systems across the continent”.

Why MENA, Why Now

Africa’s pharmaceutical sector is a key growth driver. The International Finance Corporation (IFC) estimates the African pharmaceuticals market could reach USD 50 billion by 2030, with an USD 11 billion investment needed to scale local manufacturing capacity (1). At policy level, UNCTAD emphasizes the importance of regional hubs and special economic zones to attract pharma investment and secure access to medicines (2).

Morocco is emerging as a strategic base: according to FMIIP, the sector generated MAD 23 billion (~USD 2.3 billion) in 2023, including MAD 12.7 billion (~USD 1.27 billion) from the private market alone (3). The Moroccan Competition Council also reports sustained growth between 2015–2019 (4). In parallel, ongoing reforms such as pharmaceutical pricing modernization and multi-country market access initiatives like the GCC centralized registration (GCC-DR) (5) are creating a more predictable and innovation-friendly environment.

New Capabilities for the Region

PL Morocco is designed to serve both French- and English-speaking Africa, providing:

Regulatory Affairs (including GCC/Maghreb pathways)
Safety & Vigilance
CMC/Quality and GMP upgrade support
Industrialization services
Digital transformation expertise

AI at the Center of the Inauguration

During the opening, PLG hosted a high-level panel on: “The key role of Artificial Intelligence in transforming the life sciences industry.”

Moderated by Jean-Luc Taborin, the discussion was grounded in PLG’s white paper “An Introduction to the Transformative Power of AI in Shaping the Pharmaceutical Industry”.

Speakers and participants discussed tangible opportunities and challenges of AI in:

R&D
Regulatory affairs
Pharmacovigilance
Quality assurance
Patient monitoring

Executive Perspectives

Xavier Duburcq, CEO of PLG , highlighted: “Establishing PL Morocco is a strategic step in our global expansion. By adding a strong local hub in Casablanca, we align our global expertise with local execution across MENA, helping clients navigate diverse regulatory systems, accelerate approvals, and scale operations more efficiently.”

Abderrahim Bouabidi, Ph.D., Managing Director of PL Morocco , added: “With over 20 years in pharma — spanning international roles at Abbott and Cooper Pharma — I have seen how the right mix of regulatory strategy, quality, and process optimization can unlock value. Our ambition is clear: position PL Morocco as a regional hub serving both French- and English-speaking Africa, supporting GMP upgrades, international registrations, and compliant growth for local and global innovators.”

Mohamed El Bouhmadi , President of FMIIP, underlined: “PLG’s arrival in Casablanca is a recognition of Morocco’s role as a strategic player in the pharmaceutical sector. The development of artificial intelligence applied to life sciences is a tremendous opportunity to strengthen our health sovereignty and support local innovation.”

Omar Sefiani , CEO of Sobrus, commented: “The digitalization of the patient journey is a major challenge to improve the quality and accessibility of care. Integrating AI into our practices opens new perspectives — from prevention to therapeutic follow-up — and creates solutions that are better adapted to the needs of Moroccan and African patients.”

A Key Milestone in the One Africa Initiative

With the opening of Casablanca, PLG strengthens its One Africa initiative, aiming to build an integrated organization across Morocco and Tunisia, harmonize processes, and deliver international-quality services to regional and global clients.

The inauguration brought together around 60 PLG employees, clients, and partners, confirming Casablanca as a strategic anchor for PLG’s presence in Africa.

PLG UK Among Best Workplaces™ 2025 in Consulting

Giulia Maffei — Mon, 15 Sep 2025 04:00:00 GMT

A milestone achievement for our workplace culture

We are proud to announce that ProductLife Group (PLG) UK has been officially recognised among the UK’s Best Workplaces™ in Consulting & Professional Services 2025 , a prestigious award granted by Great Place to Work® .

This recognition reflects the voices of our colleagues and the trust they place in the culture we are building together. It highlights our ongoing commitment to creating a workplace where people feel valued, supported, and empowered to grow.

Building a people-first workplace

Being ranked among the Best Workplaces™ in Consulting & Professional Services underlines our strong people-first approach. At PLG UK, we believe our greatest strength lies in our people, and we are committed to fostering an environment where everyone can:

Feel valued for their contributions and expertise
Be supported through inclusion and collaboration
Grow and thrive thanks to continuous development opportunities

Great Place to Work® recognition across 12 countries

Beyond the UK, ProductLife Group is Great Place to Work® certified in 12 countries worldwide . This global achievement demonstrates our shared commitment to building a workplace culture defined by inclusivity, trust, and respect—enabling our teams to deliver meaningful impact for both clients and patients. Together we are stronger

At ProductLife Group, we know that our strength lies in our people . Being named one of the UK’s Best Workplaces™ 2025 in Consulting & Professional Services reinforces what we already believe: together, we are stronger, and together, we are shaping a workplace built on trust, respect, and opportunity.

Building a Local Safety Officer Program

ADMINUSER — Mon, 07 Jul 2025 04:00:00 GMT

Key Considerations and Best Practices

Introduction Beth Shaleesh, RN, MS, MBA, Head of Pharmacovigilance Account Management for North America, delivered an insightful presentation on the fundamental considerations involved in building a Local Safety Officer (LSO) or Local Person Responsible for Pharmacovigilance (LPRP) program. This presentation highlighted the significance of correctly establishing such programs and the myriad of benefits they provide to organizations in terms of compliance, efficiency, and public health protection.

Importance of the LSO Program As global regulations become more complex and more products are marketed globally, t he LSO program is indispensable for several key reasons. First, it is a legal requirement in many countries around the world to fulfil the local pharmacovigilance regulations. These legal stipulations ensure that companies remain compliant with local, regional, and international pharmacovigilance regulations, thereby avoiding legal repercussions and fines. Second, an effective LSO program works closely with the Marketing Authorization Holder (MAH) to equip organizations with the expert knowledge necessary to navigate the evolving pharmacovigilance landscape and complex global regulations . Third, one of the primary goals of the LSO program is to minimize risk. By ensuring that all pharmacovigilance activities are conducted accurately and timely, the program helps protect patient safety and public health, thereby enhancing the organization's reputation and trustworthiness. Finally , the LSO program serves as a crucial support system for the MAH’s pharmacovigilance activities. By acting as a local expert, the program ensures that the MAH’s obligations are met efficiently and effectively. The LSO program encourages a strong partnership with the MAH, aiming to meet and exceed the MAH’s objectives. This collaboration extends to supporting competent authorities’ inspections and ensuring that all pharmacovigilance activities are transparent and compliant .

Key Considerations When embarking on the journey of building an LSO/LPRP program, several critical considerations must be addressed. It is essential to ensure that the vendor chosen for the LSO program has a global presence and resources in locations that align with the organization’s future growth requirements. This will help reduce/eliminate the need for multiple vendors and more complex oversight in the future. Considerations should also include whether the services are subcontracted, performed by vendor staff, or a mix of both, and how oversight of these operations is managed. A well-thought-out organizational structure that maximizes support by incorporating a global reach with a local acting model requires regional coordination, oversight, and global governance. With these in place, it will facilita te process harmonization and maximize performance quality, efficiency and cost-effectiveness .

PLG deploys an LSO Coordinator (LSOC) to serve in this capacity. With 5 to 10 years of experience in team management and pharmacovigilance operations , a science-related degree, excellent organizational and interpersonal skills and effective communication abilities to ensure smooth and efficient operations , the LSOC begins work on the project during the transition phase (prior to go live), assisting the team to mitigate risks and ensure that the project starts on the right footing, paving the way for long-term success. Working with the client and PLG stakeholders, the LSOC is instrumental in developing and managing a transition plan which is vital to timely and precise project implementation thereby , minimizing disruptions and ensuring continuity of operations. The partnership and client support continues post go-live allowing the client partner to minimize oversight demands and have a single point of support when working with global model complexities.

PLG’s LSO/LRPPV Offering Under the guidance of the LSOC, PLG offers comprehensive services that encompasses several key elements. These services include but are not limited to:

Fulfillment of the a nominated contact person for National Health Authority who assists the Marketing Authorization Holder (MAH) to oversees the local pharmacovigilance system and backup system, ensuring that all processes are in place and functioning correctly..

Monitoring of official authority websites for safety information that may impact the organization’s products or operations.

Pharmacovigilance audit and inspection support

Assistance with safety-related communications, ensuring that all actions are carried out promptly and efficiently.

Pharmacovigilance training ensuring that all team members are knowledgeable and compliant with regulatory requirements.

Local case management activities, processing of safety information from receipt, triage, translation of local source documents to submission of ICSR to local health authorities

Performing local literature screening of local journals for identification of safety information

Processing Medical Information inquiries, handling product complaints, adverse event reporting, submissions, and report writing

Case study A noteworthy case study involves a global pharmaceutical company that partnered with PLG to manage its local pharmacovigilance (PV) and regulatory activities across more than 40 countries, including regions in the EU, MENA, JAPAC, and the Americas. The scope of services included the nomination of local responsible persons, local regulatory intelligence, literature surveillance, ICSR case management, and additional support such as RMPs, PSUR submissions, aRMM implementation, and PV training.

Challenges and Actions Taken The implementation of this global affiliate outsourcing program faced several challenges, notably the need for a seamless transition of local oversight and the ability to adapt to evolving affiliate needs. PLG addressed these by:

Selecting experienced local PV specialists and qualified vendors to ensure compliance and efficiency.

Rapidly setting up a global operating model with regional coordination and global governance.

Developing innovative tools such as a local ICSR tracking system and automated reconciliation solutions.

Implementing global and local pharmacovigilance technical agreements (PVTAs) to harmonize responsibilities and ensure consistency across affiliates.

Post Go-Live Monitoring Following the go-live, PLG established a robust monitoring framework that included:

Centralized tracking of all local ICSR activities to enable global HQ oversight.

Monthly performance reports and governance meetings to ensure transparency and quick issue resolution.

Continuous monitoring of KPIs, all of which have been successfully met to date.

Current Project Status Since its inception, the project has scaled significantly, now involving 48+ PLG experts, including hybrid PV/RA resources. Over 1,000 local ICSRs were managed in the first eight months alone. The client’s satisfaction has led to ongoing expansion of the program in some of its key markets, reinforcing PLG’s role as a trusted partner in global PV and regulatory support.

Conclusion This case study highlights the importance of building a scalable and compliant LSO/LPRP program. By leveraging experienced personnel, innovative tools, and a flexible operating model, PLG has demonstrated its ability to meet complex local and global pharmacovigilance requirements while maintaining high standards of quality and client satisfaction. For more information or to discuss how PLG can support your organization in building an LSO/LPRP program, please contact our team.