Quality & Regulatory Services

Quality & Regulatory Services

Faster Approvals, Minimized Risk, and Enhanced Patient Safety

Versiti’s Quality and Regulatory services equip therapeutic developers with the expertise to navigate complex regulations and ensure compliance. We work to advise and streamline regulatory strategies, optimize global filings, and enhance submission quality through expert scientific writing. Quality strategies and vendor management improve efficiency and ensure robust processes, while our accredited IRB services through Salus IRB and Pearl IRB safeguard ethical oversight and trial integrity. By minimizing risks and optimizing timelines, these services help developers focus on delivering innovative therapies to patients efficiently.

Contact Us to Discuss your Quality and Regulatory Need

 
Regulatory Authority Guidance
Explore regulatory guidance. Expertise in filings, strategy, and compliance for seamless product development.
 
Regulatory Strategy & Pathway Mapping
Versiti Clinical Trial Services delivers expert regulatory strategies and global filings to accelerate product approvals. Trusted guidance for life sciences and medical innovations.
 
Quality Strategy Services
Achieve FDA and global compliance with quality systems, supplier audits and risk management programs through Versiti Clinical Trial Services.
 
Technical & Scientific Writing
Versiti Clinical Trial Services offers expert technical and scientific writing services, ensuring accuracy and clarity in regulatory submissions, clinical trial documentation and more.
 
Global Regulatory Filings
Expert regulatory filings with FDA and global authorities. Versiti Clinical Trial Services delivers seamless eCTD and submission support.
 
Vendor & Supplier Management
Explore Versiti Clinical Trial Services’ supplier management services including supplier management and development, technical support, and GxP auditing services.