We provide an extensive range of high quality medical writing services to our clients. Our medical writing team comprises highly qualified personnel mainly from the medical and pharmaceutical background with several years of experience in medical writing. Our writers have extensive experience in a wide range of documents across multiple therapeutic areas. Along with the clinical and regulatory experience, they possess expertise in document development and management. We undertake complete medical writing services spanning drug development phase to regulatory submissions. Our writing staff works closely with the clients team in unison with our Clinical, Medical, Regulatory, and Quality Control groups to organize, write, edit, and produce precise documentation for a wide variety of therapeutic areas and devices.

Medical Writing Services include:

• Protocol development and writing
• Development of Investigator Brochure
• Preparation of Subject’s Information Sheet and Informed Consent Form
• Integrated Clinical and Statistical study reports according to the ICH-E3 guidelines
• Translation of medical scientific essays
• Case Report Form and Patient Diary development
• Subject narratives
• Preparation of manuscripts, abstracts and product monographs
• Other relevant medical documents, e.g. handling and working manuals for CRAs
• Summary of product characteristics
• Development and review of Integrated Summary of Safety and Efficacy (ISS/E).

All our medical writing services are compliant with standard guidelines and regulations. We have internal quality control reviews at each drafting stage to ensure accuracy and consistency of the documents. We ensure timely delivery of clear, concise and scientifically sound documents to our client in a cost-effective and customized way.