Regulatory Affairs
Preparing your strategy and dossier for successful product registration and global lifecycle maintenance of your approved products
PLG regulatory affairs support
We provide comprehensive regulatory solutions across the entire product lifecycle. Our expertise covers all product types, phases of development, and global markets. Our solutions are flexible and designed to meet each client’s specific needs. We have decades of experience and expertise in all clinical, non-clinical, and CMC regulatory disciplines. Building on our legacy as the premier provider of local regulatory expertise, we support your global projects. Our dedicated professionals are ready to help you succeed with all your regulatory needs.
PLG supports our clients with regulatory affairs services through the entire product lifecycle
Regulatory strategy and roadmap consultation for global markets
Scientific advice meeting coordination with health authorities
Health agency coordination for all types of pre-authorization activities and registration applications (CP, MRP, DCP, NDA, ANDA, BLA, national applications)
Preparation of product information (SmPC, PIL, Labelling, SPL) as per regional requirements
Market-specific dossier review, authoring, and compilation for initial or follow-up registrations
End-to-end lifecycle maintenance submissions (renewals, variations – Type I/II, CBE/CB30/PAS, Marketing Authorization Transfers, Line Extensions, PSURs)
EU MAH (Marketing Authorization Holding) and US Agency services
Local Regulatory contact/representative services
Regulatory affiliate support in Europe and international markets
National phase/labeling change management support
Price and reimbursement application coordination support
Educational material review
Certificate of Pharmaceutical Product (CPP) applications
Sunset clause management
KEY FIGURES
1000+
Average annual volume of Module 1 compiled
50+
Projects PLG provides local representative services
5
Clients PLG has ongoing partnerships with to review promotional materials
50
Regulatory Reports generated monthly
Every patient matters: at PLG, we have zero tolerance for non-compliance and ensure the most up-to-date licenses are on the market to reflect the utmost quality, safety, and efficacy of medicinal products worldwide.
Natashia de Casamassimi
Head of Regulatory Affairs, ProductLife Group
