Accurate and Ethical Reporting to  Regulatory Agencies for New Drug Applications and Biologics

Our Medical Writing team is dedicated to:

  • Creating appropriate documents needed for new product approvals
  • Completing projects according to the highest quality and ethical standards
  • Helping clients streamline their document generation processes, with quality results
  • Sharing knowledge to help companies produce successful submissions and to help others become successful Medical Writers


  • Clinical Study Protocols and Protocol Amendments
  • Investigator Brochures (IB) and required IB Updates
  • Clinical Study Reports
  • Clinical Safety and/or Efficacy Patient Narratives (any size project)
  • Reports of Integrated Analyses – Integrated Summary of Safety (ISS) & Integrated Summary of Efficacy (ISE)
  • eCTD Module 2.7 Summaries for Clinical Safety and Efficacy
  • Redact, Rewrite, Reuse, and/or Repurpose content for specific audiences, eg, overly-expanded Investigator Brochures


Substantive editing:

  • Review document structure for logical flow, inter-document and intra-document consistency, grammar, and sentence structure
  • Review content for compliance with ICH* Guidelines, Regulatory Guidance, and current Regulations
  • Revise for authors writing in English as a second language

*The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

Quality Control (QC) Review:

  • Verify content and data versus source documents
  • Review lists of abbreviations for accuracy and inclusion
  • Confirm compliance with corporate and Pprofessional style manuals

Clinical Document / Submission Project Management

We can help you manage your critical-path clinical document generation by:

  • Supporting management team with submission and Rresource planning
  • Creating project-specific and/or Ccorporate style guides for consistency across documents
  • Providing leadership and planning support throughout the project
  • Supporting authors with clinical document review and finalization meetings
  • Developing realistic timelines while staying within the plan

Training / Consulting

On-site / Remote (WebEx) Workshops:

  • Understanding the electronic Common Technical Document (eCTD)
  • Writing the Integrated Summary of Efficacy (ISE) & the associated Section 2.7.3 Summary of Clinical Efficacy
  • Writing the Integrated Summary of Safety (ISS) & associated Section 2.7.4 Summary of Clinical Safety
  • Writing Clinical Patient Narratives
  • Understanding and Practicing Ethics in Regulatory Writing
  • Good Document Review Practices

In addition, we can provide  Customized Training for your needs!