Global Regulatory Filings
Compliance with global health authorities, including FDA, EMA, and PMDA.
Navigating the complexities of global regulatory filings requires expertise and precision. Versiti Clinical Trial Services simplifies this process by providing comprehensive services to bring your pharmaceutical, biologic, diagnostic or medical device products to market efficiently and compliantly to impact the greatest number of patients around the world.
Our seasoned experts manage all interactions with health authorities, ensuring seamless submissions across clinical, non-clinical, CMC, design controls, 21 CFR Part 11 and companion diagnostic requirements.
We support global filings, including:
- IND, NDA, ANDA, IMPD, CTA, MAA
- BLA, HUD, HDE
- Drug Master File (eDMF)
- 505(b)(2), ANDA
- IDE, CE Mark, 510k, PMA
- Premarket Tobacco Application (PMTA) and Modified Risk Tobacco Product (MRTP)
- Orphan drug and device designation
- Fast track designations
- Expanded access/compassionate use submissions
- Certificates of origin
End-to-end eCTD services:
- Project management and document preparation
- Formatting, hyperlinking and publishing
- Initial submissions and ongoing maintenance
- eCopy preparation for 510k and PMA devices
- Compliance with U.S., E.U. and Japan-specific requirements
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.