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.


  • 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

Formulation Support

  • Preformulation and research study focused on the physicochemical properties of a new drug candidate that could affect the drug performance and the development of a drug dosage form. Provide important information for formulation design. Every drug has intrinsic chemical and physical properties which must be considered before pharmaceutical formulation. Objective of preformulation study is to develop the elegant, stable, effective and safe dosage form.
  • Laboratory development and formulation. Proposal and formulation of the drug dosage form (solid, semisolid, liquid). Proposal of suitable packaging material for new drug dosage form.
  • Other activities: cooperation with manufacturing site and compliance with GMP. Pilot production, technology transfer into pilot (registration) batch size. Validation and evaluation of first three pilot batches, proposal and preparation of the validation protocol and report.
    • Clinical batch: proposal and preparation of manufacturing (Batch Manufacturing Record) and approval (Product Specification File) documentation for the clinical batch production. Supervision during clinical batch production.
    • Standard production: technology transfer into standard manufacturing batch size. Validation and evaluation of first three manufacturing batches. Supervision during technology transfer and validation process. Proposal and preparation of the validation protocol and report.

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