Our medical writers are qualified scientists in biomedical sciences and experience in the pharmaceutical industry, clinical research organizations, or academia. Our medical writers may support you with the preparation of documents required within clinical research, regulatory affairs, or for scientific purposes. Our medical writers become an extension of your team by being flexible to your scope, using their expertise to guide you through your clinical data to demonstrate the efficacy of your drug and improving patient safety.
We can prepare the documents in accordance with the Eurasian Economic Union or local guidelines and in full compliance with the requirements. Medical and CMC writing services include:
- Evaluation of the dossier to identify missing parts and provision of the justification for the absence
- Consultations and the preparation of the following documents:
- Readability User Testing Reports or Bridging Reports (Module 1.3.4)
- Risk Management Plans (1.8.2)
- Quality Overall Summary (QOS) (Module 2.3)
- Non-clinical Overview/Summary (Modules 2.4/2.6)
- Clinical Overview/Summary (Modules 2.5/2.7)
- Module 4 and Module 5
For any inquiry regarding our services, please contact Biomapas Business Development team.