Drug Actives from Bench into Market.
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Regulatory  Affairs  Service

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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“Regulatory Affairs is a key function for the success of a drug.”