Medical Writing

Medical writing services are a core offering at Syner-G. We know that quality is the most important factor in producing any document. Our highly experienced team of medical writers is committed to providing you with clear and concise documents that are sound from both a scientific and regulatory perspective.

Extensive Experience
The medical writing staff at Syner-G has significant experience authoring a variety of regulatory documents across a wide range of therapeutic areas and all phases of development. Our team has authored hundreds of clinical study reports (CSRs), clinical protocols, Investigator Brochures, and components of Investigational New Drug (IND) applications.

In particular, our medical writers have extensive experience authoring the clinical components of marketing applications, including New Drug Applications (NDAs) and Biologics License Applications (BLAs) in the US and Marketing Authorization Applications (MAAs) in Europe. Collectively, they have written portions of more than 50 marketing applications.

Following the submission of NDAs and BLAs in the US, we are frequently asked by our clients to assist them in authoring Briefing Documents in support of FDA Advisory Committee Meetings.

Document Types

Syner-G’s medical writing services include, but are not limited to, authoring the following document types:

  • Marketing Applications
    – Integrated Summaries of Efficacy (ISE) and Safety (ISS) for US submissions
    – Clinical Components of Common Technical Document (CTD) Module 2: Clinical Overview (Module 2.5);
    – Summary of Clinical Efficacy (Module 2.7.3); and Summary of Clinical Safety (Module 2.7.4)
  • Nonclinical and Clinical Pharmacology Summaries and Overviews
  • CSRs (across all phases of development)
  • INDs and IND Amendments
  • Orphan Drug Applications and Annual Reports
  • Investigator Brochures
  • Clinical Protocols and Amendments
  • Safety Narratives
  • Development Safety Update Reports (DSURs)
  • IND and NDA Annual Reports
  • Regulatory Agency Briefing Documents
  • Advisory Committee Briefing Packages
  • Pediatric Study Plans (US)
  • Pediatric Investigation Plans (PIPs) (EU)
  • Medical Communications

      Procedures to Ensure the Highest Quality
      Standard operating procedures are in place to ensure all documents undergo thorough quality control and scientific reviews prior to delivery to our clients.  We can prepare your documents using our suite of ICH-compliant templates and style guide or using Sponsor-provided materials; in either case, our team produces documents that are of the highest quality with regard to formatting and style as well as scientific content.

      Fellowship Program

      Our Medical Writing Fellowship Program is for professionals looking to gain experience in the medical/regulatory writing field. Fellows will be exposed to a variety of regulatory documents related to the clinical development of investigational and marketed drugs and biologics.

      Details are Available Here

      Document Types

      Syner-G’s medical writing services include, but are not limited to, authoring the following document types:

      • Marketing Applications
      – Integrated Summaries of Efficacy (ISE) and Safety (ISS) for US submissions
      – Clinical Components of Common Technical Document (CTD) Module 2: Clinical Overview (Module 2.5);
      – Summary of Clinical Efficacy (Module 2.7.3); and Summary of Clinical Safety (Module 2.7.4)

      • Nonclinical and Clinical Pharmacology Summaries and Overviews

      • CSRs (across all phases of development)

      • INDs and IND Amendments

      • Orphan Drug Applications and Annual Reports

      • Investigator Brochures

      • Clinical Protocols and Amendments

      • Safety Narratives

      • Development Safety Update Reports (DSURs)

      • IND and NDA Annual Reports

      • Regulatory Agency Briefing Documents

      • Advisory Committee Briefing Packages

      • Pediatric Study Plans (US)

      • Pediatric Investigation Plans (PIPs) (EU)

      • Medical Communications

          Procedures to Ensure the Highest Quality
          Standard operating procedures are in place to ensure all documents undergo thorough quality control and scientific reviews prior to delivery to our clients.  We can prepare your documents using our suite of ICH-compliant templates and style guide or using Sponsor-provided materials; in either case, our team produces documents that are of the highest quality with regard to formatting and style as well as scientific content.

          Fellowship Program

          Our Medical Writing Fellowship Program is for professionals looking to gain experience in the medical/regulatory writing field. Fellows will be exposed to a variety of regulatory documents related to the clinical development of investigational and marketed drugs and biologics.

          Details are Available Here

          Headquarters

          2 Park Central Drive, Suite 110
          Southborough, MA 01772

          Contact Us

          508.460.9700
          info@synergbiopharma.com

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