MakroCare provides wide range of high quality writing services for Biotech, Pharmaceutical and Medical devices companies across the Globe. Our team of qualified and experienced Medical Writers is well equipped to write a wide range of Regulatory, Clinical, Scientific and Marketing communication documents.
MakroCare has comprehensive understanding of various Regulatory guidelines such as ICH-GCP, FDA, EMA guidelines. Our team consisting of persons with qualifications in Medical, Pharmaceutical and other Life Science subjects (MD, PhD and Masters) has expertise across therapeutic areas.
MakroCare Medical Writers can help you to prepare clear, concise, and high quality reports and documents for Regulatory Submissions, publications in peer-reviewed medical journals and effective marketing communications. Our writers undergo continuous training with professional organizations.
OUR MEDICAL WRITING FOCUS AREAS
| Regulatory Writing | Scientific / Med Comm |
|---|---|
| Synopses, Protocols | Abstracts |
| Lay Summaries | Manuscripts |
| Investigator Brochure, ICF | Write-ups |
| Clinical Study Reports | Slide decks |
| Clinical Summaries and Overviews | CME Documents |
| Narratives | Poster Content Writing |
| Annual/Periodic Safety Reports | |
| PSURs/ PBRERs, PADERs, DSURs and RMP | |
| Non-clinical Study Reports | |
| Non-clinical Summaries and Overviews |
With years of hands-on experience, our Writers have the expertise to understand and analyze complex medical information and data and prepare complex documents in accordance with relevant guidelines. Helping them in this process are qualified Subject Matter Experts (SMEs), Biostatisticians, Data Analysts, Quality Analysts, and the Editing and Language Support team.
All documents are managed, created, accessed, shared, modified and stored in a validated web-based document management system (or we can work in Client environment of EDMS/RIM via Cloud/VPN).
Let's talk about how MakroCare can help you