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.

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.

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.