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Petri Dishes with Experiment

Nonclinical Writing & Strategy

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Our Expertise in Action

Successful drug development starts with a strong foundation in nonclinical strategy and scientific communication. Our Nonclinical Strategy and Writing services support the development of high-quality, regulatory-compliant documents that articulate the scientific rationale, safety, and pharmacology of your product. Whether you need full strategic guidance or expert writing support, we help ensure your nonclinical data tell a clear, compelling story that aligns with regulatory expectations. 

Writing on Tablet

Nonclinical Writing & Strategy Services

Nonclinical development strategy and regulatory planning 

Gap analyses and data interpretation

Nonclinical study protocols

Regulatory response support and briefing documents

Nonclinical study reports

Target product profile (TPP) and development roadmaps

Investigator brochures (IBs)

Scientific and technical literature reviews

Pharmacology, pharmacokinetics, and toxicology CTD summaries

Nonclinical publications and presentations

Technology Solutions 

We are thought leaders on the use of automation/logic-based programming and AI for patient data and patient-facing documents. Innovations include: 

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AgileWriter.ai™

First-in-class AI tool for composing and managing clinical trial documents

 › ​Learn more

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Quillyx™

eCTD templates that pass technical validation of submissions

 › ​Learn more

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VeriSync™

Co-authoring sync monitoring tool for Microsoft Word

 › ​Learn more

Synterex also is a Microsoft Cloud AI Partner, which positions us to work closely with product management at one of the largest tech companies in the world to advocate for clients and deliver best-in-class user experiences.

Learn more about how we're leveraging technology for the good of the patient.

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