Biopharma
Bringing a biopharmaceutical product to market is one of the most demanding undertakings in the life sciences industry.
The pathway from early discovery to regulatory approval and beyond requires coordinated expertise in science, regulation, quality, and clinical development. These disciplines must operate in parallel across multiple geographies and adapt to evolving regulatory frameworks.
Our drug development expertise covers the entire pre-approval process. We support non-clinical and toxicology programs that meet international standards, CMC development, quality system implementation, and regulatory affairs strategy. We also manage submissions across major markets, including EMA, FDA, and national authorities worldwide.
Our clinical development team offers strategic and operational support in study design, trial management, and data governance. We ensure the evidence generated is robust, submission-ready, and aligned with payer expectations.
After approval, PLG’s lifecycle management ensures your product stays compliant, competitive, and accessible as markets evolve, requirements change, and your portfolio grows.
Whether you are a large multinational advancing a complex biologic or a smaller company launching your first asset, PLG offers the expertise and global reach to support you at every critical decision point.
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Medtech
Navigate Regulation, Demonstrate Safety, Accelerate Access
The medical device and in vitro diagnostic industry is navigating one of the most significant regulatory transitions in its history. The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have fundamentally raised the bar for market access, clinical evidence requirements, and post-market obligations — creating both compliance pressure and strategic opportunity for companies that plan ahead.
PLG’s MedTech team combines regulatory expertise with deep knowledge of MDR and IVDR frameworks to support device and diagnostic companies through every phase of the product lifecycle. From initial regulatory strategy and technical documentation through quality management system design, clinical evaluation, and post-market clinical follow-up, our specialists work alongside your teams to ensure your products meet European and international requirements efficiently and sustainably.
Success in today’s MedTech environment demands more than regulatory compliance — it requires proactive evidence generation, robust quality systems, and the ability to turn post-market data into actionable insights that support continuous improvement and regulatory dialogue. Our goal is to help you maintain market access, protect your product’s position, and build the foundation for long-term commercial success.
Our 5 MedTech services — Medical Device and MedTech Services, MDR & IVDR Compliance, Quality Management Systems, Post-Market Surveillance, and Clinical Evaluation & PMCF — are designed to work as an integrated offer or to complement your existing capabilities where specialist support is needed most.
Health
Consumer Health
Navigating the Consumer Health Landscape with Confidence
The consumer health sector sits at a critical intersection; where regulatory rigor meets commercial opportunity, and scientific credibility must align with consumer trust and market differentiation.
From nutraceuticals to cosmetics and dermatology products, this space demands expertise that goes beyond traditional pharmaceutical pathways. Products face evolving regulatory frameworks across global markets while competing for consumer attention in crowded, fast-moving categories.
Beyond Compliance
PLG supports consumer health companies throughout the entire product journey with integrated solutions designed for this unique sector:
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Self-Care Product Strategy – Strategic planning that aligns your product vision with regulatory pathways and market opportunities from day one
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Regulatory and Compliance Consulting – Expert navigation of complex requirements across markets, whether managing multi-country portfolios, expanding geographically, or executing Rx-to-OTC switches
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Market Access & Reimbursement – Positioning strategies that unlock coverage and reimbursement potential in markets where consumer health products qualify
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Consumer Insights & Brand Strategy – Translating scientific evidence into compelling, credible messaging that resonates with end users and healthcare professionals alike
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Lifecycle Management – Sustaining product performance through reformulations, label expansions, new indications, and portfolio optimization
Our approach combines deep regulatory knowledge with commercial perspective; ensuring your consumer health products are not only compliant and approved, but strategically positioned to succeed in competitive markets.
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Startups &
Investors
Startups & Investors
Supporting the Life Sciences Ecosystem, From First Milestone to Successful Exit
Innovation in life sciences doesn't move forward on science alone. Startups need to de-risk their path to market fast enough to attract funding, while investors need to know that the science and the regulatory pathway behind a deal will hold up under scrutiny.
As a Privileged Partner of EIT Health's Venture Centre of Excellence, PLG helps early-stage companies build the credible regulatory pathway their next funding round depends on. For investors — venture capital, private equity, and life sciences companies alike — PLG provides independent commercial, regulatory, and manufacturing due diligence, from target screening through post-merger integration.
PLG works with both sides of this ecosystem.
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