Pharmaceutical Registration:
CTD Quality Module

Independent Pharmaceutical Consultant

• Compilation of Module 3: Quality/ CMC Dossiers
• Quality Overall Summaries for CTD, Module 2.3
• Generation of a cohesive approach in the Quality Module
• Dossier Reviews and Expert Reports
• Responses to Regulatory Agencies' comments
• Dossier updates, licence variations, renewals and new presentations
• European DMFs and Certificates of Suitability compiled
• Development and Management of CMC/ Quality projects from CTX to MAA

Experience includes

• Human and Veterinary products
• Biotechnology
• Vaccines
• New active principles, DMFs
• Novel and traditional dosage forms
• Responses to regulatory issues
• Collaboration with the R&D, production and QC staff
• Development programme specification and management

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