Rely on DRA to ensure that you have all the CMC documentation required for a successful application process and fast market access. Our highly qualified experts specialise in CMC writing and preparing documents for pharmaceutical products including plans, reports and applications in CTD and other global formats.
Our CMC writing services include:
- Documentation and expert reports for medicinal products and active substances
- US marketing authorisation applications (NDA and ANDA), annual reports and supplements
- Plans and reports, e.g. validation, product development and stability
- Responses to requests for supplementary information
- Certificate of Suitability (CEP) applications to EDQM
- Evaluation of documentation (Due Diligence and Gap Analysis)
Depend on DRA for CMC writing for your chemical or biological pharmaceutical products and drug substances. Our services cover the documentation needed for Module 3 of Common Technical Documents (CTD), and other global formats, including preparing variation packages for submission (Module 1-3, Part I-II, ASMF). In addition, you can ask to write various pharmaceutical and chemical reports and plans.
Documenting and demonstrating quality at every step of a pharmaceutical product’s life cycle is essential for applying for and maintaining marketing authorisation, and you can depend on DRA to get it right. Our team will use their chemical, medicinal, analytical, authority and industry expertise to ensure that all the necessary CMC details are included. Our team will also ensure that your CMC documentation complies with the latest revisions and amendments to the relevant guidelines and codes of the concerned market. In Europe, this includes documentation for the Finnish Medicines Agency (Fimea), the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines and HealthCare (EDQM).
We prepare high quality documents to ensure fast application processes without unnecessary questions from Authorities. The better the documentation, the faster the product gets to the market.
DRA Consulting is now PharmaLex Finland
As we are merging with the global service provider PharmaLex, our name has been changed to PharmaLex Finland.
Biological medicines: how does their manufacturing process differ from traditional medicines?
The differences in the manufacturing process and the nature of the active substance itself mean that biologicals differ from traditional medicines in many ways.