We support our customers in registering and implementing drug regulations and guidelines issued by international regulatory authorities during drug development and approval.

• Preparation of regulatory documents
• CMC sections for IND and CTA submissions
• CMC sections for NDAs and MAAs submissions (CTD format)
• Drug Master Files (Europe and US)
• Preparation of CMC briefing documents for meetings with regulatory authorities


• Regulatory consulting services
• Regulatory concepts and strategies for submissions
• Support for technical development and registration of drugs
• Technical advice on requirements for manufacturing, control as well as preclinical and clinical testing of biotech products

Regulatory Affairs supports the Process Development, Scale-Up and Manufacturing, making time to market as swift and smooth as possible.

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