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Regulatory CMC

Cilatus Regulatory Services consulting team includes senior pharmaceutical regulatory experts with extensive experience in CMC regulatory affairs for both large and small molecules at all stages of development. The team is experienced in all aspects of global pharmaceutical regulation, due diligence, research, development, technology transfer, commercialisation, life cycle management and compliance. Areas we can assist you with include:

  • CMC regulatory strategy development and implementation.
  • Critical review and assessment of Module 3
    • We define the right level of content for your regulatory submissions.
  • Drafting, preparation and review of regulatory documentation
    • including Module 2.3 Quality Overall Summary, Module 3 of IND/IMPD, NDA/BLA/MAA, scientific advice briefing documents etc.
  • Liaison with regulatory agencies.
  • CMC submission project management.
  • Provide strategic advice on the interpretation and application of CMC regulatory guidances.
  • Advise on Quality by Design (QbD) programs and requirements for regulatory filing including developing CQA reports.
  • CMC Regulatory gap analysis and mitigation.
  • Manufacturing technology transfer and comparability strategies.
  • Change control and Marketing Authorisation (MA) compliance.
  • Review of cGMP/GMP documentation e.g. validation reports, analytical methods, batch records, stability protocols etc...
  • CMC Regulatory reviews for Due Diligence activities.