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Other Services Include

  • Training courses in Regulatory Affairs.
    • We provide tailored training programs to the pharmaceutical industry based on the client’s requirement.
  • Information service: regulations, medicinal products, market analysis
  • Short Term Engagements and Trouble Shooting. We can assist you on short notice when unexpected issues arise in operations or in relation to Regulatory filings or inspections:
    • Un-bureaucratic engagement on short notice
    • Major issues in product development or during production
    • Major issues in QC and analytical testing
    • Unexpected responses or major concerns from Regulatory Authorities
  • Due Diligence and Partnering. Cilatus Regulatory Services can assist with the regulatory aspects of due diligence and partnering. Through our sister company Cilatus Biopharma Consulting we can offer complete solutions for due diligence and partnering projects. Our services include:
    • Establishment of due diligence team, timelines, communication flow and deliverables
    • Management of and participation in the review process: review of data room information and identification of missing information, gaps and impact assessment
    • We can assist you with all aspects of partnering including strategic analysis of the product(s), technology or company, identifying and engaging with potential buyers.