Pharmaceutical Development Consultancy Our understanding of the current challenges facing the pharmaceutical industry enable us to provide personalised responses to your Drug Development or Regulatory CMC needs We help you meet your objectives: - Sound scientific & regulatory strategies - Clear and accurate quality documentation - 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