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
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 Development & Validation
Versiti Clinical Trial Services offers end-to-end biomarker development and validation services, empowering translational research and personalized medicine advancements.
Regulatory Authority Guidance
Explore regulatory guidance. Expertise in filings, strategy, and compliance for seamless product development.
Quality & Regulatory Services
Versiti’s Quality and Regulatory services equip therapeutic developers with the expertise to navigate complex regulations and ensure compliance.