Synergy Pharm USA:
a Contract Medical Writing Organization
The writing of your pharmaceutical documentation at Synergy Pharm is a guarantee of quality and rigor, but also of compliance with deadlines. Depending on your needs, you can entrust us with the writing of a wide range of regulatory and clinical documents for submission to national and international regulatory authorities, including:
- Common Technical Documents (CTD) to ICH standards: Clinical and Nonclinical
- Investigator’s Brochures
- Clinical Trial Protocols
- Clinical Trial Reports (Phases I to IV)
- Literature Review Reports
- Evaluation Reports for Medical Device
- Investigational Medicinal Product Dossier (IMPD) for Clinical Trial Authorizations (CTA)
All our documents are prepared to ICH standards and in accordance with your standard operating procedures (SOPs) following signature of a confidentiality agreement.
Our added value:
In writing your scientific documents, our critical eye as outsiders makes it possible to identify potential errors in the data or in their analysis, and to highlight these at the outset, thereby avoiding problems further down the line. In addition, quality control is undertaken by another writer in the team at each stage of the writing of your clinical and medical documentation.