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Medical Writing

DDReg undertakes writing of various medical documents that form part of submission dossier, Medical content or those required for Drug Safety Management. DDReg has a team of experts who have experience working in a broad rang of indication and therapeutic areas. They can assist in developing Medical content, preparing expert overview & summaries, writing PSURs, Risk Management Plans, Core Data Sheets etc. Our Medical Writing services follow ICH guidelines and are compatible with similar regulatory requirements.

 

Our Medical Expertise includes (but not limited to) development/ authoring/ compilation/ compilation/ preparation of 

  • Non Clinical Overviews & Summaries
  • Clinical Overviews & Summaries
  • Company Core Data Sheets/ Company Core Safety Sheets
  • Medical Content including Patient Education Materical, Product Monographs, Medical brochures
  • Periodic Safety Reports/Annual Safety Reports/ Risk Management Plans, Risk Evaluation and Mitigation Stratgies
  • Summary of Product Charateristics (SmPC)/ Prescribing Information (PI)
  • Process Document, Process Maps, Operating Procedures 

 

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Phone: + 91 (0) 124 4361505, 4361506, Email: info@ddreg.in