The Science-First Full Service CRO and Regulatory Partner for Biologics

Advance Your Biologic Through Development to Approval and Commercial Success

Advancing biologics from start to finish is highly complex and full of challenges, requiring scientific strategies and implementation. Veristat’s global team leverages lessons learned over the course of our work, supporting more than 375 clinical trials and consulting projects, 40 INDs/CTAs, and 20 marketing applications for biologic therapies in the past five years.

Trust Veristat to guide your success in mitigating risks and efficiently bringing your biologic towards its next development milestone, all while ensuring patient safety and access. Over 80% of Veristat global operations team members have biologics clinical development experience.

Developing a biologic therapy?

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We understand how high the stakes are for your biotherapeutic. Nothing is standard when developing novel therapies, demanding more complex clinical program planning, and involving a complicated regulatory approval process.

As your strategic partner, Veristat ensures that your clinical trial or program design supports your regulatory strategy in this specialized area. Our experienced teams are ready to plan and launch your trial:

Full-service clinical trial planning and project management
Clinical site management and monitoring
Biometrics expertise including data management, biostatistics, statistical programming, and data standards implementation
Medical writing of clinical trial and regulatory submission documentation
Strategic regulatory consulting including tailored CMC support
Preparation of regulatory marketing applications

Home > Biologics

Podcast: Regulatory CMC Considerations for Planning Comparability Studies for Biotherapeutics Development

Comparability studies pose a significant issue for those working in biotherapeutics development, as undetected product changes are considered high-risk. Learn the importance of comparability studies for biologics, key aspects of assessing comparability, and how to successfully plan your clinical and CMC manufacturing development plans.