Background

Pharmaceutical development, 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 (IMPD) and marketing authorization applications (Module 3). 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

  • 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 biowaivers

We view BCS-based biowaivers as a smart, ethical, and cost-efficient path to faster product launch.
Our expertise helps you:

  • Leverage existing data on permeability, absorption, and bioavailability
  • Identify what additional evidence is needed for BCS I or III classification
  • Prepare strong, well-reasoned justifications

With our prospective approach, we help you avoid pitfalls related to excipients, dissolution profiles, and unnecessary analytical testing - saving both time and resources.