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Full-Service CRO of Choice for Biologics 

Advance your biotherapeutic through the clinical development journey to approval and commercial success. 

Advancing biologics from start to finish is highly complex and full of challenges, requiring bold scientific strategies and implementation. This class of therapies requires versatile planning and development, from cell & gene therapies to mRNA vaccines to monoclonal antibodies and more.  Veristat’s global team leverages lessons learned during our work supporting more than 250 clinical trial and consulting projects, 13 IND/CTAs, and 8 BLAs/MAAs for biologics and biosimilars in the past 3 years.  
 
Delivering high-quality results in a timely and efficient manner is our strength. 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.  

In the past 3 years, Veristat has conducted over 40 full-service biologics trials,
30% being viral gene therapies. 

Offering End-to-End  Clinical Trial and Consulting Expertise

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:

Your Global Partner in Biotheraputic Development | Case Studies

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. 

Reg Podcast Oct22 Version A

Ensure a sound strategic, clinical and regulatory plan tailored to your needs– speak with our experts today 

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Learn More with These Resources

Case Study

Helping a Sponsor Overcome a Partial Clinical Hold and ...
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Newsletter

Advancing Your Biologic Requires Bold Scientific Strategies
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Case Study

A Comprehensive Planning Approach for Cancer Antibody
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