Your Partner in Regulatory Success
Navigating the regulatory landscape can be challenging, but our team of experienced consultants works closely with you to design tailored regulatory strategies, ensuring your product reaches the market faster and more efficiently to impact the lives of patients everywhere.
Services:
- Regulatory strategy development: Aligning your business goals, risk tolerance and budget with the optimal regulatory path
- Global registration plans: Maximize data re-use across clinical, non-clinical, CMC and testing data for global filings
Expert Global Filings
We have extensive expertise in managing interactions and submissions with global health authorities, ensuring compliance and timely approvals.
Our services include:
- Filing submissions in eCTD format via FDA’s ESG
- Formatting eCopy submissions for 510(k) and PMA devices
- Comprehensive support for INDs, NDAs, IMPDs, BLAs and more
Submission Types We Support
Solutions across a wide range of filings, including:
- IND, NDA, ANDA, CTA, MAA, BLA
- 505(b)(2), HUD, HDE, CE Mark
- Orphan drug/device designation
- Expanded access/compassionate use
Formulation, CMC Development, Strategy Services & Oversight
Versiti Clinical Trial Services performs validation and safety testing services for IVD, medical devices, pharmaceuticals, biopharma, assays and equipment.
Quality Strategy Services
Achieve FDA and global compliance with quality systems, supplier audits and risk management programs through Versiti Clinical Trial Services.
Global Regulatory Filings
Expert regulatory filings with FDA and global authorities. Versiti Clinical Trial Services delivers seamless eCTD and submission support.