PLG provides Product Development consulting services covering:

– Regulatory science and global development strategy (incl. consultations with agencies)

– Full CMC development and related QA & QP services (incl. interaction with CDMOs, EU batch certification and release)

– Nonclinical development strategy consulting & operational support

– Clinical development strategy consulting & operational support

– Market access at global and local level

– Regulatory procedures and documents: briefing packages, ERA, PDE, ODD, PIP, biowaivers CCDS / CCSI…

– Medical writing & publishing: IND / CTA, (A)NDA / BLA, all eCTD modules, study reports

– Clinical trials applications management

– Marketing Authorization procedures management (EU CP / DCP / MRP, US NDA / BLA)

The team offers flexible consulting approach tailored to Biotechs regulatory needs and works in close collaboration with their partners. Their global network of senior regulatory & CMC experts allows to support all modalities, therapeutic areas and interact with all major regulatory agencies.

–  Therapeutic areas: Consulting services covering all therapeutic areas and drug modalities

–  Based in: Headquarter in Courbevoie (FRANCE) DSI Harleysville (US Affiliate)

–  Employees: 500+

–  Created in: 1993