Regulatory Writing Services

Clinical

  • Clinical Study Protocols

  • Case Report Forms (CRFs)

  • Investigator Brochures (IBs)

  • Clinical Study Reports (CSRs) (Phase I-IV)

  • Informed Consent Forms (ICFs), patient information

  • Clinical safety narratives/summaries

Regulatory Submissions

  • Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Biologics License Applications (BLAs), Marketing Authorisation Applications (MAAs), Premarket Approval (PMA) applications

  • Clinical and preclinical summary sections of the Common Technical Document (CTD/eCTD): 
    Sections 2.2, 2.4, 2.5, 2,6, 2.7, Integrated Summary of Safety (ISS), and Integrated Summary of Efficacy (ISE)

  • Initial Pediatric Study Plans (IPSP)

  • Orphan Drug Applications

  • Annual Reports

  • Drug Safety Update Reports (DSURs)

  • Pre-meeting packages, briefing documents, and Sponsor responses for regulatory agencies

  • Risk Evaluation and Mitigation Strategy (REMS), Risk Management Plans (RMP)

  • Summary of Product Characteristics (SPC/SMPC)

Pharmacovigilance

  • Adverse Event (AE) & Serious Adverse Event (SAE) Narratives

  • Annual Safety Reports 

  • Periodic Adverse Drug Experience Reports (PADERs) 

  • Periodic Adverse Experience Reports (PAERs) 

  • Periodic Benefit-Risk Evaluation Reports (PBRERs)

  • Periodic Safety Update Reports (PSURs)

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