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Regulatory Affairs

We prepare customised, high-quality registration dossiers in CTD format of our Active Pharmaceutical Ingredients to be used for national procedures, European procedures or ANDAs.
Our services regarding registration of APIs include in detail:
Life Cycle Management of existing products
  • Regulatory support for marketed products
  • Continous improvement of documentation
  • Update service and handling of variations
  • Long-term management of „Stability testing“
Regulatory Affairs

Copyright 2008. The United States Pharmacopeial Convention. Reprinted with permission. All rights reserved

Preparation of registration dossiers:
  • Compilation of registration documents according Notice to Applicants und Common Technical Document Standard
  • Preparation of chemical- pharmaceutical Dossiers (CMC, Part II), basing on raw data.
  • Drug Master File: Handling of EU Drug Master Files and US Drug Master Files
  • Submission of documentation to EDQM for receipt of CEP
  • Preparation of Technical Information Packages
  • Handling of Letter of Access and further regulatory statements
Management of registration procedures:
  • Assurance, that, all information provided in registration application and registration documents are consistent with actual guidelines and that all documents are going to be prepared in predetermined time-frames.
  • Handling of deficiencies in technical matters as well as in form and content.
  • Competent personal contact during all stages of validation and registration.

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