Regulatory and Clinical Documentation

Synergy Pharm USA:
a Contract Medical Writing Organization

Our team is experienced in regulatory medical writing. By entrusting the writing of your pharmaceutical documentation to Synergy Pharm, you are guaranteed quality and rigor, as well as a writing schedule that complies with your deadlines.

We have experience in writing a wide range of regulatory documents for clinical trials to be submitted to national and international regulatory authorities most notably for your Clinical Trial Applications (CTAs) or your drug Marketing Authorization Applications (MAAs).

• Before the Clinical Study
  • The Investigational Medicinal Product Dossier (IMPD) for Clinical Trial Authorizations (CTAs)
  • Investigator’s Brochures (IBs)
  • Clinical Study Protocols

• After the Clinical Study
  • Clinical Study Reports (CSRs Phases I to IV)
  • Lay Summary

• Marketing Authorization Application (MAA)
  • Common Technical Documents (CTDs) to ICH standards: Clinical and Nonclinical
  • 120-Day Safety Update or 4-Month Safety Update (4MSU)
  • Drug Abuse Liability Assessment (DALA)
  • Pediatric Investigation Plans (PIPs)

• Medical Device
  • Clinical Evaluation Reports (CERs) for Medical Devices

Please note that this is not an exhaustive list of our services. Our team of medical writers has extensive experience in producing high-quality clinical trial, pharmaceutical, and medical device documentation. We provide other medical writing services for all your clinical projects, including synopses, Informed Consent Forms (ICFs), and responses to questions from regulatory authorities (such as the European Medicines Agency [EMA] and the Food and Drug Administration [FDA]), as well as your pharmacovigilance documents (Periodic Safety Update Report [PSUR]/Periodic Benefit-Risk Evaluation Report [PBRER], Development Safety Update Report [DSUR]).

Please do not hesitate to contact us to discuss your needs.

We sign confidentiality agreements for all of our projects. All our documents are prepared to ICH standards and in accordance with your standard operating procedures (SOPs).

The added value of our services

Entrusting the writing of your scientific documents to our team gives you opportunity to have your project critically reviewed by our experienced writers, allowing us to identify any potential errors in the data or in their analysis at the outset and allowing you to avoid any problems further down the line. Quality control is a key component of our medical writing strategy: the quality of your project will be verified by another medical writer in our team at each stage in the process of writing of your clinical and medical documentation.

Biostatistical analyses

For biostatistical analyses of your clinical studies, including services and support during the design of the study, writing of the statistical analysis plan, the programming of models and post-hoc analyses, you can contact our partner QualityStat.