Medical Writing

Experience across different therapeutic areas you can trust.

In the success of a clinical research project, medical and regulatory documents prepared with scientific accuracy, reporting clarity, and regulatory compliance by experienced medical writing teams plays a crucial role.

Our Medical Writing team has vast experience in all phases of clinical development and regulatory submissions and works closely with key operational departments including Data Management, Biostatistics, Medical Affairs, Quality Assurance, Regulatory and Clinical Operations. Our professional service encompassing all regulatory obligations will be tailored to your needs.

Our highly experienced team of medical writers works on a variety of activities projects from initial protocol development to clinical study reports (CSR) and final dossier for regulatory documentation as per SOW. The team has in-depth knowledge in clinical domain.

Our medical writing services include clinical and regulatory writing, as well as scientific papers, education material and medical writing consultancy. They work directly with you to ensure consistency with your format and style while maintaining full compliance with regulatory requirements and International Conference on Harmonization (ICH) guidelines, Schedule Y and any other guidelines if applicable. Additional regulations and guidelines, eg, drug-class or indication-specific guidance of the Food and Drug Administration (FDA) or other regulatory authorities may be followed as agreed with the Customer before the start of writing.

• Clinical Study Report and Narratives
• Clinical Study Protocol and Protocol Amendment
• Informed Consent
• Investigator Brochures
• Common Technical Document (CTD)
• Integrated Summaries of Efficacy (ISE) and Safety (ISS)
• Investigational New Drug (IND) and New Drug Application (NDA) submission
• IND Annual Report
• Product Label
• Briefing Document (as agreed with Customer)
• Product Development Plan (as agreed with Customer)
• Journal Article and Literature Review
• Subject Narratives
• Clinical Trial Registry Synopses

• Abstracts
• Manuscripts
• Posters
• Literature summaries
• Slide presentations
• Symposia publications
• Publication plans