Medical Writing

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Medical Writing is a vital segment of clinical research. It plays a critical role in the development and submission of clinical research documents and defines the success or failure of new medicinal products. Our team of qualified and experienced Medical Writers is well equipped to write a wide range of Regulatory, Clinical and Scientific documents. BLA Regulatory has a comprehensive understanding of various regulatory guidelines such as ICH-GCP, FDA, and EMA. With a qualified team of skilled and experienced medical writing professionals from pharmaceutical and clinical research industries, BLA Regulatory develops quality documents, coordinates peer and client reviews, performs quality checks, and accomplishes the project management of various regulatory, clinical writing activities in both Electronic Common Technical Document (eCTD) and CTD modules. Our expertise includes:

  • eCTD modules for IND, NDA, BLA
  • Fast Track, Breakthrough Therapy, Priority Review Applications
  • FDA Meeting Request and Briefing Package
  • Orphan drug application
  • Integrated Summaries of Efficacy (ISE), Integrated Summaries of Safety (ISS), and Integrated Summaries of Immunogenicity (ISI)
  • Interim data summaries
  • Clinical Summaries and Overviews
  • Nonclinical Summaries and Overviews
  • Clinical Pharmacology Study Protocol
  • Synopses, Protocols and Protocol Amendments
  • Clinical Study Report (CSR)
  • Nonclinical Study Reports
  • Investigator Brochures (IB)
  • Informed Consent Forms (ICF)
  • Pediatric Study Plan (PSP)
  • PK/PD, TK, and population PK reports
  • Safety narratives and Safety update reports
  • Study Reference Manual
  • Annual/Periodic Safety Reports – PSURs/ PBRERs, PADERs, DSURs and RMP