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
Authoring Module 1 documents for all types of regulatory activities – IND, IMPD, CTA, NDA, ANDA, BLA, MAA, Renewals, Variations, Line extensions, 61(3) notifications.
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
Promotional Material ReviewEducational material review
Certificate of Pharmaceutical Product (CPP) applications
Sunset clause management
Regulatory Intelligence