Chemistry, Manufacturing and Controls (CMC) Development

Gap Analysis / Due Diligence

• We thoroughly assess your data to identify any potential issues/gaps that can have an impact on securing clinical trial and/or future marketing approvals; and propose risk-mitigation strategies to address those gaps and smooth product development pathway to approval.
• Identify any possible deficiencies in preparation for:
  • Scientific Advice
  • Internal portfolio evaluation
  • Licensing due diligence
  • Investment negotiations

Module 3 (CMC) Dossier

• Full authoring and review of the entire CMC dossier for Clinical Trial Authorisation (CTA), Investigational New Drug (IND), Marketing Authorisation Application (MAA) and Biologics License Application (BLA)/New Drug Application (NDA).
• Expert reports and summaries including Quality Overall Summary (QOS).

Rescue Projects/Remediation

• Advice and direct input into addressing the technical scientific questions/matters raised by different regulatory health authorities, and/or other development roadblocks, to ensure a positive outcome.