Application Sector
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.
Biopharmaceutical drug development services
Expert biopharmaceutical consultants accelerating your drug from discovery to launch with proven strategies
Regulatory Affairs Services
Comprehensive global regulatory support for all product types and lifecycle stages, backed by decades of local and international expertise.
CMC & Quality: Pharma's Pathway to Excellence
Guiding drug development to regulatory approval, ensuring safe, high‑quality medicines.
Non-clinical and toxicology development
Design and oversee non-clinical programs bridging discovery to first-in-human trials, ensuring IND readiness, GLP oversight and CRO governance.
Clinical development services
Integrated clinical development operations delivering strategy, adaptive trial design, robust CRO governance, GxP quality, global execution for regulatory success.
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.
Medical device and medtech services
Comprehensive regulatory and development support across the product lifecycle, from concept through commercialization and beyond.
MDR & IVDR compliance
Expert guidance navigating MDR and IVDR requirements, ensuring compliant transitions and sustained market access.
Quality management systems
ISO 13485-compliant QMS design, implementation, and optimization tailored to your organizational needs and regulatory requirements.
Post-market surveillance
Structured PMS systems that meet regulatory obligations while generating actionable insights for product improvement and risk management.
Clinical evaluation & PMCF
Rigorous clinical evaluations and post-market clinical follow-up strategies that demonstrate ongoing safety and performance.
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:
- Self-Care Product Strategy – Strategic planning that aligns your product vision with regulatory pathways and market opportunities from day one
- Regulatory and Compliance Consulting – Expert navigation of complex requirements across markets, whether managing multi-country portfolios, expanding geographically, or executing Rx-to-OTC switches
- Market Access & Reimbursement – Positioning strategies that unlock coverage and reimbursement potential in markets where consumer health products qualify
- Consumer Insights & Brand Strategy – Translating scientific evidence into compelling, credible messaging that resonates with end users and healthcare professionals alike
- 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.
Nutraceuticals
Strategic regulatory and compliance guidance for dietary supplements and nutraceutical products, from formulation and claims substantiation through global market authorization.
Cosmetics and Dermatology
Expert regulatory and scientific support for cosmetic and dermatological products, navigating safety assessments, compliance requirements, and market-specific regulations globally.