Clinical writing and development solutions for today's needs

Synterex is a WBENC-Certified Women's Business Enterprise and disability-owned global clinical and regulatory consulting firm that provides clinical writing and development solutions.

Our staffers are seasoned and dedicated, with extensive experience doing the work hands-on, as well as in building and leading teams.

We are committed to applying our years of experience, current subject matter expertise, and technical knowledge to help clients deliver important new therapies to patients in an expedient manner.

Clinical Science

Medical monitoring/site communications support, document development (CRFs, study manuals, ICFs), line listing review/data cleaning, data presentations (safety review, publications, etc.), and medical coding/deviations review

Regulatory Documents

Protocols/amendments, briefing books, IBs, CSRs, narratives, annual reports, INDs, and NDAs/BLAs

Electronic Publishing Services (eCTD format)

Formatting, publishing, and submission through gateway

IT Collaboration Services

Office 365 support and training (workflows/automation, co-authoring, SharePoint), mobility services, and more

Additional Services

Publications, literature searches/reviews, narrative automation, SOPs, redaction, training, and more

How can we help you?

We have a proven ability to provide strategic direction across a broad spectrum of therapeutic areas.

“I have worked with Synterex for several years at 2 different small pharma companies. Jeanette and her team provided expert guidance and support for several regulatory submissions, including an NDA and MAA. Most recently they prepared a Phase 2 protocol and 2 IBs and DSURs, enabling us to push forward our key programs. The Synterex team is very knowledgeable and responsive and work well with our internal development team. I continue to rely on their support and highly recommend them to my industry colleagues.”

-John McCartney, PhD, Head of Medical Writing, Verastem Oncology

"Synterex has been a key factor in our recent success through their provision of consistent medical writing and project management expertise. We appreciate their reliability, creativity and ability to deliver major global submissions. Their agility in the face of shifting scope and timelines, and their professionalism and positive demeanor overall, have supported successful regulatory filings leading to drug approval. As a result we have expanded our portfolio of global submission documents outsourced to them."

- Director, Medical Writing, mid-sized biopharmaceutical company

Synterex has years of experience in clinical writing and development for the following therapeutic areas:

Allergy and Immune-Related Disorders

  • Allergy
  • Immuno-oncology
  • Inflammation


  • Immuno-oncology
  • Vaccines
  • Supportive Care
  • Radiopharmaceuticals
  • Biologics
  • Hematologic Malignancies
  • Solid Tumors

Rare Disease

  • Gene Therapy
  • Metabolic Disorders
  • Bone Disorders


  • CNS
  • Multiple Sclerosis
  • Ophthalmology
  • Generics
  • ADME Studies
  • Opioids/Pain Management
  • Sleep Disorders
  • Orthopedics

Our mission statement

Delivering quality regulatory documentation requires navigating an evolving landscape, influenced by regulators, research committees, health care professionals, and most importantly, the scientific method itself. At Synterex, we forge lasting and meaningful relationships that flex with the dynamic nature of science and technology.