Nonclinical Writing & Strategy
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.
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:
AgileWriter.ai™
First-in-class AI tool for composing and managing clinical trial documents
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.