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Setting your documents on the right path

Synterex, Inc. is a woman-owned consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support.

Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug development through post-approval.

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.

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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

Clear
Concise
Accurate