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

Our staffers are seasoned and dedicated, with extensive experience doing the work hands-on as well as building and leading teams. We are committed to applying our years of experience and current subject matter and technical knowledge to help clients deliver important new therapies to patients in an expedient manner.

SYNTEREX

Our Services

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

Additional Services

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

IT Collaboration Services

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

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

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

Mission Statement

Delivering quality regulatory documentation requires navigating an evolving landscape influenced by regulators, research committees, healthcare 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.

AGILE

A- Accessible
G- Growth-oriented
I- Innovative
L- Lean
E- Expert

Testimonials

“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

Therapeutic Areas:

Allergy and Immune-Related Disorders

  • Allergy
  • Immuno-oncology
  • Inflammation

Oncology

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

Rare Disease

  • Gene Therapy
  • Metabolic Disorders
  • Bone Disorders

Other

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

Why Choose Us

  • SYNTEREX

    Clear

  • SYNTEREX

    Concise

  • SYNTEREX

    Accurate