Insight Medical Writing

Experts in regulatory writing

Experts in regulatory writing

  • Regulatory
    documentation
  • Pharmacovigilance
    documentation
  • Clinical trials
    documentation
  • Medical marketing
  • Data Disclosure
    and Transparency
  • Electronic
    submission publishing
    and support
  • Translation
  • Regulatory documentation

    Clear, concise regulatory documentation is critical to the success of any drug development programme.

    As a specialist writing provider with a proven track record of success, our wealth of experience in this area ensures smooth progress through submission to approval.

    • The Common Technical Document (CTD)
      • Clinical summaries
      • Clinical overview
      • Non-clinical summaries
      • Non-clinical overview
    • New Drug Applications (NDAs)
    • Marketing Authorisation Applications (MAAs)
    • Supplemental NDAs and MAA variations
    • Core dossier preparation
    • Regulatory responses
    • Integrated safety and efficacy summaries (ISS/ISE)
    • Clinical study reports (Phase I - IV)
    • Serious adverse event (SAE) narratives
    • Clinical Evaluation Reports (CERs)
    • Non-clinical reports
    • Briefing documents
  • Pharmacovigilance documentation

    Insight has a strong background in providing a wide range of high quality pharmacovigilance documentation. For over 10 years, Insight has been at the forefront of the development of EU Risk Management Plans (RMPs). This expertise extends to all safety documents.

    • Risk management plans (RMPs)
    • Periodic safety update reports/Periodic benefit-risk evaluation reports (PSURs/PBRERs)
    • Development safety update reports (DSURs)
    • Post authorisation safety/efficacy studies (PASS/PAES)
    • Medical assessment advice as required
  • Clinical trials documentation

    Our dedicated team provides specialist writing support through each step of the development process. Precise, unambiguous documentation ensures successful implementation and completion of the clinical trial process. Our attention to detail is second to none.

    • Clinical development plans
    • Protocols
    • Protocol amendments
    • Patient information
    • Investigator brochures and updates
    • Paediatric information plans
  • Medical marketing

    Clinical data are accurately and concisely presented for a variety of different audiences.

    • Manuscripts
    • Presentations and posters
    • Conference proceedings
    • Abstracts
    • Educational CDs
    • Product monographs
    • Newsletters/brochures
    • Attendance at Advisory Board meetings
  • Data disclosure and transparency

    Transparency in clinical development has been progressively formalised in legislation that requires data to be made publicly available in the form of lay summaries, data registries and redacted submission documents (including the Clinical Study Report, Clinical Summary and Clinical Overview). While information that is either commercially sensitive or might identify individual patients may be redacted in the public documents, this content must be agreed in advance with the appropriate authority, and achieving the right balance can be complex.

    Insight is well placed to support and facilitate your data transparency obligations. We are proficient at preparing lay summaries, ensuring that often complex concepts are explained in a clear and easily accessible manner. Our writers have also been trained on the new redaction requirements and ensure a proactive approach is taken from the first draft, pre-empting and minimising the need for later efforts. In addition, our redaction specialists focus on tools, techniques and procedures that facilitate identification and justification of information to be redacted.

  • ePublishing and support

    With the increasing demand for electronic submission of regulatory documents, Insight MW has partnered with an established provider of specialist publishing services. Our experienced team can offer wide-ranging support and consultancy for all aspects of electronic submissions in Europe, the US and the Rest of World, including compilation and project management of electronic CTD (eCTD), non-electronic eCTD (NeeS) and Paper submissions. We understand that project needs vary and can offer publishing support on everything from individual documents to full applications.

    • International team with experts in the US and Europe
    • Format and render documents to PDF
    • Make documents submission ready
    • Check compliance with applicable guidelines
    • eCTD/NeeS submission compilation including creation from metadata
    • Validation of submission
    • Paper submission
    • Provide technical support by phone or email
    • Function as the technical contact for the agency
    • Advise on aspects such as:
      • Submission structure, type and sequence
      • Life Cycle Operation applicability and use of documents
      • Granularity
      • File naming
      • Formatting
      • PDF requirements (eg hyperlinking, bookmarks, inherit zoom)
  • Translation

    Global development programmes and international submissions require specialist translation services. Our partnership with a leading translation company ensures seamless transition between languages. We offer access to a broad team of translators who are well-versed in the requirements of the pharmaceutical sector, ensuring your documents are accurately converted using appropriate terminology. We understand the challenge of tight timelines, so final documents are formatted to allow direct incorporation by the publishing team.