The Verity Collective offers deep regulatory expertise across the life sciences landscape, backed by a team of Subject Matter Experts (SMEs) with decades of global experience. Our professionals have led regulatory strategies for products across every stage, from early development and clinical trials to approval and post-market compliance. With former FDA officials and industry veterans in our network, we provide actionable guidance and hands-on support for submissions, agency interactions, and global regulatory planning. Verity helps organizations navigate complex requirements with clarity, speed, and confidence.
Regulatory Support Without the Guesswork
Navigating global regulatory requirements can be complex, but it doesn’t have to be. Verity’s experts bring decades of hands-on experience managing submissions, health authority interactions, and regulatory strategy across every phase of the product lifecycle. From INDs and CTAs to NDAs, BLAs, and post-market filings, we help streamline the process and reduce delays.
Every regulatory pathway is different. That’s why we take a tailored approach, aligning our strategy with your goals, risk tolerance, and timelines. Whether you need end-to-end support or targeted expertise, Verity delivers clear, actionable guidance that moves your program forward with confidence.
Submissions
We can help you answer the tough questions while guiding your organization on the best way to properly select and implement various systems.
Our primary areas of focus are:
- Computerized Systems, Software, & IT Validation
- IT Roadmap Creation and Deployment
- Data Integrity & IT Compliance Audits
- Independent Program Oversight of Software Implementation
Strategy
In order to get submission ready our consultants can help guide on current industry best practices and give support where needed. We tailor our advice to be phase appropriate while preparing your organization with the necessary steps and timelines that will make you best prepared to become commercial ready.
Areas of support may include:
- Pre-Submission Activities
- Global Trial Planning
- Response Letters
- Working with Multiple Markets
- Accusitions and business Integrations
- Drug Developmental Issues
