For over 20+ years, MakroCare is providing high quality medical writing services for Biotech, Pharmaceutical, Consumer Health and Medical Devices companies across the Globe. Our team of well qualified and experienced Medical Writers have deep experience in writing Regulatory, Clinical, Scientific and MedCom areas.
MakroCare has comprehensive understanding of various Regulatory guidelines such as ICH-GCP, FDA, EMA guidelines. Our team consisting of professionals with qualifications in Medical, Pharmaceutical and other Life Science subjects (MBBS, MD, PhD and Masters) has expertise across therapeutic areas.
MakroCare Medical Writers can help you prepare clear, concise, and high quality reports and documents. Our writers undergo continuous training with professional organizations.
Medical Writing Focus Areas
| Regulatory Writing (Clinical & Non-clinical) | Other |
|---|---|
| Protocols, Synopsis, ICF, IB | Annual/Periodic Safety Reports |
| CSR | Manuscripts |
| Patient/Safety Narratives | Abstracts/Manuscripts |
| Clinical Summary/Overview | Med Info Documents |
| Non-Clinical study Reports | |
| Non-Clinical Summary/Overview |
With years of hands-on experience, our Medical Writers have the expertise to understand and analyze complex medical information as well as data (clinical, scientific, non-clinical, safety) and prepare complex documents with relevant guidelines. Helping them in this process are qualified Subject Matter Experts (SMEs), Biostatisticians, Data Analysts, Quality Analysts, Editing and Language Support team. An independent QC team ensures extra layer of scrutiny before documents are delivered to you, to reduce your QC or Oversight burden.
All documents are managed, created, accessed, shared, modified and stored in a validated web-based document management system.
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