Our full range regulatory affairs solutions and services are dedicated to delivering the highest quality support, assistance and regulatory approvals. We follow the needs of our customer and their portfolios, as we work with a wide range of product categories: medicinal products, medical devices, cosmetics, and food supplements. Our Regulatory Affairs team has comprehensive expertise and assures quality and accuracy for each task. All team members have majored in life sciences.
Dossier Development / Medical Writing
Our medical writers are qualified scientists with PhD degrees in biomedical sciences and experience in the pharmaceutical industry, clinical research organizations or academia. Biomapas’ 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 with a view to demonstrating the efficacy of your drug and improving patient safety.
We can prepare documents in accordance with your template and style guide, or use our own templates, in full compliance with national and international regulatory guidelines. All projects undergo thorough scientific, statistical, editorial and quality control review. Regulatory affairs and pharmacovigilance medical writing services include:
- Full Dossier development;
- Readability User Testing Reports or Bridging Reports (Module 1.3.4);
- Risk Management Plans (1.8.2);
- Environmental Risk Assessments (Module 1.6);
- 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;
- Summaries of product characteristics (SPCs) and Package leaflets (PL);
- Periodic safety update reports (PSURs).
We have been a member of EMWA (European Medical Writers Association) since 2010.
For any inquiry regarding our services, please contact Biomapas Business Development team.