Pharmaceutical and Chemical Services

Are there changes to the manufacturing process, supplier of raw materials or the manufacturing site? Is your documentation in compliance with requirements?

Guidelines and codes are amended and revised continuously, yet we stay on top of things. Let us provide the expertise! Our team specialises in preparing documentation, with know-how based on long-term experience in the pharma industry and regulatory assessment (Fimea and EDQM).

Appropriate documentation is the key to a successful application process.

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Our expertise covers

  • Documentation on chemical and biological medicinal products and active substances (Module 1-3, Part I-II, ASMF)
  • US marketing authorisation applications (NDA and ANDA), annual reports and supplements
  • Expert reports
  • Various plans and reports (e.g. validation, product development and stability)
  • Responses to requests for supplementary information
  • CEP applications to EDQM
  • Evaluation of documentation (Due Diligence).

Our application for the transfer of manufacturing site was approved a few months earlier than expected, without any additional questions or comments! Thank you for the awesome collaboration.

The report was very clear and written in very good English – it was a joy to read! I wish all validation reports were like this.

We can provide you with variation packages ready for submission. We will compile the CTD sections, classify variations and provide justification for changes. We will help you find the fastest route to success, without delays or unnecessary requests for further information – every time.

Do you wish to improve your understanding of Module 3 or interpret stability data? Order training!

DRA Academy

Pharmaceutical chemistry reports related to the manufacturing and quality of medicinal products are an essential part of marketing authorization applications and the maintenance of marketing authorizations. You must be able to demonstrate quality at every stage of the product’s life-cycle.