Regulatory affairs consulting

Preparing your strategy and dossier for successful product registration and global lifecycle maintenance of your approved products

Female mentor teaching employees group analyzing online project explaining strategy

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.

Sometimes you have to have difficult conversations. Shot of a group of businesspeople in a meeting at work.

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 Review

Educational material review

Certificate of Pharmaceutical Product (CPP) applications

Sunset clause management

Regulatory Intelligence

KEY FIGURES

1000+

Average annual volume of Module 1 compiled

50+

Projects PLG provides local representative services

Clients PLG has ongoing partnerships with to review promotional materials

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