Regulatory
Strategic Services to Advance Your Goals
Navigating the global regulatory landscape requires a proactive, strategic approach to ensure compliance, accelerate approvals, and optimize product development. Our Regulatory Strategy and Operations services support companies across all stages of the product lifecycle, from early development planning to post-approval regulatory maintenance. Whether you need high-level strategic guidance, hands-on submission management, or expert regulatory operations support, we provide customized solutions to meet your needs.
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Global regulatory strategy development
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Regulatory roadmap for early and late-stage development
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Consulting for expedited approval pathways (e.g., orphan drug, RTOR) and designations
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Interpretation of regulatory guidance and disease-specific advice
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Regulatory intelligence and policy monitoring
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Kickoff meeting leadership (submissions and individual documents)
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Meeting coordination and stakeholder input management
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Regulatory CMC consulting
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Support for critical FDA communications and responses
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Preparation for regulatory interactions (pre-IND, EOP2, pre-NDA, Advisory Committees)
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.