Medical Writing
We offer a fully integrated medical writing services that meet the high demands of the regulatory processes involved in the development of drugs. Our highly experienced team of medical writers with clinical, medical, and regulatory expertise is committed to provide the clear and concise documents that are sound from both a scientific and regulatory perspective.
Our medical writing services include:
- Clinical Development Plan
- Clinical Study Protocol development
- ICH E3 compliant Clinical Study Report (CSR)
- Patient Safety Narratives
- Informed Consent forms (ICF)
- Investigator Brochure (IB)/Core Data Sheets (CDS)/ United States Prescribing Information (USPI)
- Investigational Medicinal Product Dossier (IMPD)
- Investigational New Drug (IND) file
- New Drug Application (US NDA)
- New Drug Submission (Health Canada NDS)
- Marketing Authorization Application (EU, UK, APAC MAA)
- Manuscripts/Abstracts
