Medical Writing Services

Our medical writing team, comprised of medical writing experts, distinguishes itself through extensive experience, which spans a wide range of therapeutic areas. Our systematic approach to each task ensures that every document produced is of the highest quality and precision. This depth of knowledge allows us to offer comprehensive support for a variety of regulatory documentation needs, tailored to the specific requirements of each project.

With broad medical writing skills, we are adept at addressing the unique challenges and nuances of each field. Our expertise in clinical research is evident in every document produced, reflecting our commitment to excellence in every phase of development.

From early-stage research to late-phase clinical trials, our writers have experience navigating the complexities of drug development. This versatility guarantees that we can provide high-quality, scientifically sound documentation that meets the stringent requirements of regulatory agencies worldwide.

We have broad-based experience across multiple therapeutic areas including, but not limited to:

– Ophthalmology⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀    – Neurology
– Oncology⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀      – Metabolic disorders
– Infectious disease⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀   – Dermatology
– Central nervous system disorders⠀     – Cardiovascular disease
– Respiratory⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀   – Gastroenterology
– Rheumatology⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀ ⠀⠀- Women’s health
– Pain management

The scope of our work encompasses various regulatory documents, each critical to the success of our clients’ projects:

• Clinical Study Reports (CSRs): We produce detailed reports that clearly present the findings of clinical studies, meeting global regulatory guidelines.
• Clinical Protocols: Our team designs comprehensive protocols that outline the objectives, design, methodology, statistical considerations, and organization of clinical trials.
• Investigator Brochures: We compile essential data on investigational products for use by clinical investigators, ensuring that it is presented clearly and concisely.
• Investigational New Drug (IND) Applications: Our writers are skilled in preparing the necessary documentation to obtain approval to start clinical trials, including detailed information about the investigational product, its manufacturing, and plans for clinical study.

Our standard operating procedures are in place to ensure all documents undergo thorough quality control and scientific reviews prior to delivery to our clients. We prepare your documents using our suite of ICH-compliant templates and style guide or using sponsor-provided materials. Our team produces high-quality documents with a focus on formatting and style, as well as scientific communications and content.

Through their commitment to excellence and our extensive experience, Syner-G’s medical writing team makes sure that all documents are crafted to facilitate the smooth progress of drug development programs and support successful regulatory submissions. 

Following submissions 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.