Medical Writing
Avoid regulatory submission and approval delays by creating high-quality documents the first time round with the help of experienced medical writers. We provide clinical and regulatory medical writing services across all phases of development.
Clinical Trial Protocols (CTP) and Amendments
Clinical Study Reports (CSR)
Investigator’s Brochures (IB)
Investigational Medicinal Product Dossiers (IMPD)
Investigational New Drugs (IND)
Common Technical Documents (CTD) Module 2 (including ISS and ISE)
Orphan Drug Designation Applications (ODD)
Paediatric Investigation Plans (PIP), Pediatric Study Plans (PSP)
Briefing Books
Development Safety Update Reports (DSUR)
Study Design and Synopsis Writing
Informed Consent Forms (ICF)
Clinical Development Plans (CDP)
Nonclinical Reports
Study design literature review, synopsis writing Clinical trial protocols & amendments Clinical study reports (CSR) Patient narratives
Pre-trial
Investigational medicinal product dossiers (IMPD) Investigational new drugs (IND)
Ongoing & Marketing Approval
Ongoing & Marketing Approval
Post-trial
Clinical evaluation reports (CER) Common Technical Document (CTD) - Clinical summaries,
HR Functions
Non-clinical overview Integrated safety & efficacy summaries (ISS/ISE) Briefing books
Open Communication
Orphan designation applications Clinical and preclinical manuscripts
Service Benefits
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