Who We Are
France is one of Europe’s leading life sciences markets, with a strong research ecosystem, sophisticated regulatory and market access requirements, and a diverse healthcare sector. Successfully bringing products to patients requires local insight, coordinated expertise, and the ability to respond effectively to evolving European and national requirements.
PLG France helps pharmaceutical, biotechnology, medical device, diagnostics, consumer healthcare, nutrition, cosmetics, and animal health organizations successfully operate in France and across international markets.
Combining in-depth knowledge of the French healthcare landscape with ProductLife Group’s global capabilities, we provide integrated consulting and outsourcing support across product development, market introduction, compliance, and lifecycle management.
Whether you are entering the French market, developing a new product, preparing for commercialization, expanding internationally, or optimizing established operations, we help you simplify complexity, reduce risk, and advance your objectives more efficiently.
PLG’s French platform brings together ProductLife France, RNI, and Nextep Health. ProductLife France incorporates the expertise and capabilities of the former Strategiqual and Stragen Services entities, while SQILS Factory serves as its dedicated training organization.
Local Services
PLG France provides comprehensive support across the entire product lifecycle.
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Regulatory Affairs
- Regulatory strategy and development planning
- National and European regulatory submissions
- Marketing authorization applications
- Regulatory intelligence and authority interactions
- Lifecycle maintenance, renewals, and variation management
- Regulatory operations, publishing, and submission management
- International registration and expansion support
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Quality & Compliance
- Quality management systems
- GMP, GDP, GCP, and related compliance support
- Inspection readiness
- Internal and external quality audits
- Audit remediation and corrective action support
- Supplier qualification and oversight
- Quality assurance and operational compliance
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Safety & Vigilance
- Pharmacovigilance services
- Medical device vigilance
- Local safety support
- Case processing and safety reporting
- Risk management activities
- Medical literature monitoring
- Benefit-risk assessment support
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Clinical Development
- Clinical development strategy and consulting
- Scientific, medical, and regulatory documentation
- Clinical operations support
- Study compliance and oversight
- Clinical research support
- Pre-approval planning and coordination
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Market Access, Pricing & Reimbursement
- Market access strategy
- Pricing and reimbursement support
- Health economics and outcomes research
- Evidence generation planning
- Value communication
- Stakeholder engagement strategy
- Policy and advocacy support
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Scientific, Toxicology & Product Expertise
- Scientific and toxicology assessments
- Safety and efficacy documentation
- Scientific and medical dossiers
- Product development support
- Claims and promotional substantiation
- Nutrition, health, and beauty product expertise
- Cosmetic and consumer healthcare regulatory support
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Digital & Operational Excellence
- Regulatory and quality digitalization
- Process optimization
- Compliance technology solutions
- Regulatory information management
- Data governance and management
- Operational transformation
- Technology-enabled lifecycle processes
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Lifecycle Management
- Post-approval regulatory support
- Product maintenance activities
- Renewals and variation management
- Portfolio optimization
- International expansion support
- End-to-end lifecycle management
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Training & Regulatory Intelligence
- Regulatory and scientific training
- Customized professional development programs
- Monitoring of regulatory developments
- Interpretation of evolving requirements
- Knowledge-sharing programs
- Support for organizational readiness
The expanded capabilities in scientific, toxicology, regulatory strategy, international expertise, quality audit, training, advocacy, due diligence, and nutrition, health, and beauty reflect the services currently offered for PLG’s French network.
Why Work With PLG France?
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Navigate the French Market with Confidence
Benefit from local expertise that helps you understand and address France’s regulatory, market access, quality, safety, and healthcare requirements while remaining aligned with wider European frameworks.
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Simplify Complexity Through One Partner
Access regulatory, quality, safety, clinical, scientific, digital, and market access expertise through a coordinated team, reducing fragmentation and making it easier to manage complex, cross-functional programs.
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Accelerate Product Development and Market Readiness
Move products forward more efficiently with practical guidance, specialist resources, and support tailored to your development stage, product category, and commercial objectives.
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Support Innovation from Strategy to Execution
Strengthen product development decisions with regulatory, scientific, toxicology, clinical, and market-access insights that help you identify requirements early and build more effective development pathways.
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Maintain Compliance While Reducing Risk
Stay aligned with evolving French and European requirements while strengthening quality, safety, and regulatory performance throughout the product lifecycle.
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Expand into International Markets
Connect local French expertise with ProductLife Group’s international network to support cross-border development, registration, commercialization, and ongoing product management.
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Scale Resources to Match Your Needs
Whether you require strategic consulting, specialist expertise, project-based support, managed services, or outsourcing solutions, our flexible engagement models adapt to your operational priorities and business objectives.
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Connect Local Insight with Global Capabilities
Leverage in-depth knowledge of the French healthcare and regulatory landscape while gaining access to ProductLife Group’s international network of life sciences specialists and proven practices.
Supporting Success in France and Beyond
Whether you are developing an innovative product, entering the French market, preparing for launch, expanding internationally, or managing ongoing compliance obligations, PLG France helps simplify complexity so you can focus on delivering healthcare solutions to patients and consumers.
By combining local market understanding with global capabilities, we help clients reduce risk, improve operational efficiency, accelerate progress, and create sustainable value across France and international markets.
Local expertise. Global capabilities. A trusted partner for every stage of your product lifecycle.
RNI
RNI is a consulting firm founded in 2006 that offers in-depth expertise in the field of regulatory and scientific affairs for nutrition, health and beauty products. RNI bridges the gap between countries so that you can achieve your domestic and international goals
Our objective is and will always be the same:
Thinking beyond mere compliance, addressing your developments and projects, even the most complex ones, in a bold and strategic way.
Advising you at every stage of your product development and helping you towards innovation in total efficiency.
Expertise
- Training RNI is an International leader in regulatory and scientific affairs and offers a range of training courses dedicated to your professional upgrading or development needs.
- Scientific & Toxicology expertise To provide you with support in your projects, in drafting your promotional arguments and your scientific, medical, toxicological or safety dossiers for submission to the authorities, or for marketing authorisation of your products.
- Regulatory Strategy To advise you at each stage of development of your products and effectively support you in innovation.
- Merger and acquisition – Due diligence – M&A Acquiring a new trademark, new factory or new business is a calculated risk. Regulatory due diligence and an acquisition audit are essential to identifying the regulatory compliance and potential of your target.
- International Expertise RNI supports you in your international export projects.
- Quality audit RNI will support you, stand in for you, or assist you with any internal or external quality audit
- Reg&Co A new all-in-one regulatory and design solution. RNI’s experts understand the challenges your company faces with product development, regulatory requirements, design, marketing, and project coordination. With ReG&Co, we deliver an All-In-One solution, providing fully compliant labels for your domestic markets and abroad for your expansions.
- Advocacy RNI engages with public decision-makers and regulatory authorities to represent and advocate for the interests of companies and the profession. Our experts monitor, anticipate, and prepare for regulatory changes through targeted training and knowledge sharing initiatives.
- Partners RNI actively participates in leading European and International trade and scientific associations, supporting collective initiatives, advocating for key positions, and advancing ideas within the profession. This engagement enables RNI to contribute to shaping European and international regulations
Nextep
Nextep, a consulting firm specialized in HealthSpecializing in strategic healthcare issues and transformation of healthcare practices, we are convinced that sustainable, virtuous transformation of the healthcare system requires a global, systemic approach.
For almost 25 years, we have been working with drug manufacturers, medtechs, medical device manufacturers, e-health startups, institutional clients and specialists in prevention and diagnostics, to help them meet their strategic challenges.We mobilize a vast ecosystem of stakeholders, working together to create more value for patients by reconciling human, business, economic and healthcare organization factors.
Our method: to act as a catalyst between people, expertise and ideas, ultimately enabling the fastest possible access to medical innovations for the greatest number of people.
Nextep deploys its services internationally, and in particular in Europe, as a founder and member of the Medvance network.
Expertise
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Market Access
- Market access strategy for European and national markets
- Generation of clinical evidence, real-world data & new data collection methodologies
- Clinical and economic evaluation & access to reimbursement in France and Europe
- Price negotiation, new contracting modalities, and stakeholder engagement
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Public Affairs
- Advocacy & coalitions
- Lobbying and public policy evolution
- Regional territories and local actions
- Communication and brand awareness
- Studies and surveys
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Strategy & Transformation
- Patient care pathway
- Strategy and research
- Organizational transformation
- Pre-launch and product launch
- Strategy and marketing
- Healthcare professional engagement
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Training and Publications
- Dedicated “Master Classes” to address the challenges of healthcare system transformation
- Analytical briefs anticipating key issues in the pharmaceutical sector
Nextep is certified ISO 26 000
Associations
SQILS Factory
Through ProductLife Group’s European and global network, clients can access expertise across regulatory affairs, quality and compliance, safety and vigilance, clinical development, market access, scientific and toxicology services, digital transformation, and lifecycle management.
Our integrated approach connects the specialized capabilities of our French teams with broader international resources, helping organizations access the right expertise at the right point in their product journey.
PLG Headquarters / Product Life France, SQILS Factory & RNI
8–14 Avenue de l’Arche
92400 Courbevoie
France
Product Life France – Office Lyon
118-126 Boulevard Marius Vivier Merle
69003 Lyon
