Background

Pharmaceutical development, Quality/CMC

We are ready to support you through the pharmaceutical product development process, leveraging our scientific, industrial and regulatory expertise to guide you to successful marketing authorization.

Our expertise includes thoroughgoing and practical knowledge of the CTD format for both clinical trials and marketing authorization applications. We actively monitor the innovations and regulatory environment and are able to interpret them. Our approach to the development issues is profound and exploratory with a priority on mutual understanding.

Chemistry-Manufacturing-Control (review of CMC data for)

  • Active Substance Master File (ASMF): Assessment/Compilation support/Quality Overall Summary
  • Certificates of suitability to the monographs of the European Pharmacopoeia (CEP)
  • Investigational Medicinal Product Dossiers (IMPD)
  • Module 3 (Quality) CTD support

Development strategy

  • Dissolution Method Development (biodiscriminative versus quality control)
  • Inhalation drug product development
  • In Vitro-in Vivo Analysis
  • Responses to Deficiency letters
  • Variations, biowaivers
  • BCS-based bioawaivers