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Regulatory Medical and Technical Writing

Our in-house team of domain specific subject matter experts help clients produce clear and suitable regulatory documents, detailing all aspects of the drug development process and CMC. Our experts have experience writing clinical study reports, NDA's, ISS/ISE's, and IND applications (including eCTD format).

  • Nonclinical and Clinical Overview Writing
  • CTD Summary Writing
  • Literature Review for Quality/BE studies / Clinical /Non Clinical Overviews
  • Preparation of Summary of Product Characteristic (SmPC), Pack Insert, and Product rationale
  • Proficiency in creating detailed NDA, ANDA, ISS, ISE, and IND applications (Module 1, 2, 3, 4 and 5)
  • Customized Dossier writing
  • Pharmaceutical Development Report (PDR) writing
  • Expert Technical Reports on Quality Module 2.3
  • Dossier updating from old EU format to CTD/eCTD
  • Literature and Brochure for medical devices
  • Annual Safety Report Writing
Regulatory Medical and Technical Writing

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Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

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