Comprehensive Formulation, CMC Development and Oversight

From formulation to regulatory oversight, we provide tailored solutions to guide your product from concept to market with confidence.

Formulation Development

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Versiti Clinical Trial Services delivers innovative pre-formulation and formulation strategies for both small- and large-molecule drugs, enhancing stability and delivery.

CMC Development and Supplier Management

Our integrated CMC services help you achieve key development milestones. From method validation to supplier oversight, we ensure quality at every step.

Read our Regulatory, Quality Compliance, and CMC Analytical Service Case Study.

Highlights:

  • Analytical method optimization and validation
  • Supplier risk management and performance monitoring
 
 

Regulatory Strategy and Oversight

Gain the strategic advantage with our regulatory expertise. Our team ensures compliance with international standards, guiding you through complex processes.

Key services:

  • IND, NDA and global submission preparation
  • Technical writing and quality strategy guidance

Global Filings Made Simple

Seamlessly navigate international regulatory requirements with our filing services. We specialize in eCTD and drug master file submissions.

 
 
Biomarker, Assay Development & HLA Typing
Discover Versiti Clinical Trial Services’ biomarker solutions featuring assay design, HLA typing, and immunogenetics to support therapeutic breakthroughs.
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Regulatory Guidance & Global Filings
Versiti offers expert regulatory strategy and global filing support to accelerate approvals, reduce costs, and ensure compliance worldwide.
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Quality & Regulatory Services
Versiti’s Quality and Regulatory services equip therapeutic developers with the expertise to navigate complex regulations and ensure compliance.
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