Your Partner in Regulatory Success
Product development pathways are becoming increasingly intricate. To succeed in navigating the regulatory ecosystem and delivering hope to patients, you need a trusted partner who understands the complexities of the domestic and global regulatory landscapes.
Versiti Clinical Trial Services offers:
- Tailored global regulatory strategies
- Expertise in regulatory authority interactions and filings
- Proven ability to trim months and costs from your development timeline
Impact for Patients around the Globe
Where clinical studies can impact populations around the globe, let Versiti guide your regulatory strategy. In our case study: "Study Startup in the U.S. for a European Sponsor" the team worked with an EU-based CRO to expand their study into Australia and the United States. Our experts guided the sponsor in highly qualified site selection that were a fit for the study logistics and timeline, while navigating the process to secure an IND, interfacing with an IRB, and facilitating communication across sites and investigators.
Why Partner with Versiti?
Our seasoned consultants bring an average of 20 years of industry experience, delivering responsive, client-focused service. We specialize in:
- Designing pathways that align with your product and business goals
- Negotiating with global health authorities for seamless approvals
- Reducing inefficiencies to accelerate time-to-market
Tailored Strategies for Your Product
From pharmaceuticals to biologics, we craft regulatory strategies that account for your unique product type and market goals.
Our expertise spans a range of regulatory submissions, including:
- INDs, CTAs, NDAs, PMTAs and more
- eCTD formatting and submission
- Strategic quality reviews and documentation