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MEDICAL WRITING

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MEDICAL WRITING

Medical Writing or Medical Communication services are the fifth most important part of product life cycle. Medical Writer has to coordinate directly with various departments such as clinical data management team, pharmacovigilance team, regulatory team, sales team and product management team. We understand how important medical writing is to pharmaceutical and biotechnology companies. In an industry where even the slightest mistake can have serious consequences, we offer a service that encompasses preparing scientifically accurate and culturally sensitive documents that are fully compliant with current regulations and adapted to the target audience.

Our medical writers have years of experience preparing clinical documents in a wide range of therapeutic areas including Oncology, CNS and Immunology among others. All medical writing experts are qualified to MSc or PhD level, have full knowledge of industry guidelines and vast experience. Additionally, they undergo regular training conducted by the EMWA (European Medical Writers Association), the AMWA (American Medical Writers Association) and other recognized medical writing organizations to keep their skills abreast as what is happening into the Pharma and Biotech fraternity.


Our medical writing services are fully compliant with ICH Guidelines and other regulatory requirements currently in force. We strictly follow our internal SOPs or apply our client’s specific SOPs, templates, and writing style for a wide variety of documents, including Regulatory, Clinical and Medical communication materials such as:

  • CTD Module 4 Non Clinical Summaries
  • CTD Module 5 Clinical Summaries
  • CTD Independent Expert Review
  • Clinical Study protocols
  • Clinical study reports (CSRs, including SAE narratives)
  • Investigator brochures, IMPDs
  • Clinical overviews and summaries
  • Medical source review reports
  • Informed Consents
  • Final Reports
  • Conference abstracts
  • Referenced Articles
  • Integrated clinical study report (as per ICH E3)
  • Newsletter