Pharmaceutical Development Consultancy Our understanding of the current challenges facing the pharmaceutical industry enables us to provide personalised responses to your Drug Development or Regulatory CMC needs
We help you meet your objectives:
Who are we?
Sound scientific & regulatory strategies Clear and accurate quality documentation
F. David
Well developed new drugs & post approval changes
Rapid approval, maximum compliance, minimal licence maintenance
Fred-CMC has expertise in the following areas: Pharmaceutical Development Drug product development from drug substance to finished product Orals, injectables, topicals (cutaneous, ocular), combinations
Regulatory CMC Strategy Dossier submission Variations Agency meetings
Regulatory CMC Documentation
CTDs (Module 3, QOS) IMPD & IND Quality sections Briefing packages Dossier variations
Engineer with Masters in Chemistry 14 years industry experience Phase 1 to postmarketing (topicals, injectables, combination products) Experience in drug product design & development, manufacturing process, scale-up & control, regulatory CMC strategy & documentation Member of TOPRA CMC SPIN group Bilingual (French-English), Native French speaker
C. Reed Pharmacist with PhD in pharmaceutical sciences 16 years industry experience Phase 1 to filing (orals, topicals) Experience in drug product design & development from drug substance to finished drug product, regulatory CMC documentation Bilingual (French-English), Native English speaker 204 route d’Auribeau 06130 Grasse St Jacques FRANCE + 33 (0) 961 048 954
[email protected]
Need some help?
tel: +33 961 048 954 e-mail:
[email protected]
