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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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In the past 5 years, Veristat has conducted:

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Biologics clinical trials and consulting projects

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are for Rare/Ultra-Rare Diseases

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of which are full-service clinical trials

Providing End-to-End Clinical Trial and Consulting Expertise for Biologics


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

Scientific Excellence in Biologic Therapy Development

Gene Therapy Indications

  • ADA-SCID 
  • Canavan Disease 
  • Congenital Adrenal Hyperplasia (CAH) 
  • Macular Degeneration 
  • Wiskott-Aldric Syndrome (WAS) 
  • And more... 
cellandgene_splicing

Cell Therapy Indications

  • Chronic Fecal Incontinence 
  • Fabry Disease 
  • Gaucher Disease 
  • Glioblastoma (GBM) 
  • Graft vs. Host Diseases (GVHD) 
  • And more… 
lab-cmc_scientistinlab

Other Indications, including vaccines

  • COVID-19 
  • Exocrine Pancreatic Cancer 
  • Fabry Disease 
  • Friedreich’s Ataxia 
  • Human Papilloma Virus (HPV) 
  • And more… 
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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

Webinar Video Replay

Align New Oncology Drug Development with FDA's Project ...
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Align New Oncology Drug Development with FDA's Project ...
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Veristat Corporate Fact Sheet
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