At Verus IP, we understand that navigating FDA regulations is critical for the successful development, approval, and commercialization of medical, biotech, pharmaceutical, and food-related innovations. Our multidisciplinary team combines intellectual property expertise with regulatory knowledge to guide clients through the complex FDA landscape efficiently and confidently.

Our FDA-Related Services Include:

1. Regulatory Strategy and Pathway Planning
We help clients identify the most appropriate FDA regulatory pathways—whether it’s premarket notification (510(k)), premarket approval (PMA), biologics license application (BLA), new drug application (NDA), or others—tailored to their product type and market goals.

2. Preparation and Review of FDA Submissions
Verus IP assists in drafting, reviewing, and managing regulatory submissions including 510(k)s, BLAs, NDAs, Investigational New Drug (IND) applications, and de novo petitions, ensuring all documentation meets FDA requirements and deadlines.

3. Compliance and Quality System Consulting
We advise clients on FDA compliance matters such as Good Manufacturing Practices (GMP), Quality System Regulations (QSR), and labeling requirements to help maintain product approvals and avoid costly enforcement actions.

4. Intellectual Property and Regulatory Alignment
Our team integrates IP strategy with regulatory planning to protect innovations throughout the product lifecycle—anticipating regulatory exclusivities and leveraging patent protections alongside FDA data exclusivities.

5. FDA Interaction and Communication Support
We facilitate interactions with the FDA, including pre-submission meetings, responses to FDA inquiries, and management of inspections or audits, providing strategic counsel to achieve favorable outcomes.

6. Post-Market Surveillance and Enforcement Support
Verus IP supports post-market regulatory obligations such as adverse event reporting, recalls, and compliance updates, while advising on enforcement risks related to IP and regulatory matters.

Why Choose Verus IP for FDA Regulatory Support?

Our holistic approach bridges the gap between intellectual property protection and FDA regulatory compliance, empowering clients to bring innovative products to market smoothly and safeguard their competitive advantage.

Verus IP: Your partner in innovation, regulation, and protection.