PLG regulatory affairs support

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 clients 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

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 



Average annual volume of Module 1 compiled


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

Natashia de Casamassimi