Topical Drug Products

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  • Development of detailed CMC product development plans (from early phase development all the way to final regulatory submission, approval and commercialization),
  • Includes creams, ointments,  lotions, gels, suppositories and patches.
  • Pre-formulation and  formulation development (including preservative evaluation, selection  and testing)
  • Container-closure and package evaluation, selection & testing  
  • Analytical and microbiological development
  • Stability testing as per ICH guidelines.
  • GMP compliance for clinical and commercial manufacturing
  • Scale-up; process development and validation
  • QC product release.
  • Technical documentation