The Kavi Law Group
At the intersection of innovation and regulation, we help early-stage and growth companies in biotech, digital health, AI, and FDA-regulated industries navigate complex legal and regulatory challenges from concept to commercialization.
With experience from top-tier law firms and in-house legal departments, we offer business-focused counsel tailored to fast-moving companies. Whether you're preparing for FDA submission, structuring clinical trials, scaling AI-enabled solutions, or securing strategic partnerships, we align legal strategy with your business goals.
You focus on innovation — we’ll handle the regulatory and legal complexity that comes with it.
Explore our services
We guide your product from concept to market by developing robust FDA regulatory strategies. Our expertise ensures your submissions meet all requirements, streamlining the approval process and facilitating a successful and compliant product launch.
Ensure ethical and compliant engagement with healthcare professionals (HCPs) and patients. We provide comprehensive HCP and patient interaction guidance, helping you navigate complex regulations related to communications, education, and support programs.
Confidently navigate mergers, acquisitions, and other business transactions with our transactional and due diligence support. We conduct thorough regulatory due diligence, identifying potential compliance risks and providing strategic insights to inform your decisions and ensure smooth transactions.
Navigate the complexities of post-market FDA enforcement with confidence. We provide strategic counsel and defense, helping you respond effectively to agency inquiries, manage recalls, and address compliance issues to protect your product and reputation.
Minimize risk and maximize impact with our advertising, promotion, and marketing review services. We meticulously assess your materials to ensure they comply with FDA regulations and other relevant guidelines, preventing potential enforcement actions and safeguarding your brand.
Establish a strong foundation for regulatory adherence with our compliance program and SOP building services. We design tailored programs and create clear, actionable Standard Operating Procedures to ensure consistent compliance across all your operations.
Access Strategic Legal Counsel for What’s Next
Stay ahead of regulatory hurdles and business risks with precise, timely legal advice designed to help accelerate your company’s momentum — not slow it down.
Connect with us today to gain the forward-thinking counsel your innovation deserves.
Your Legal Partners in Innovation
Meet the team that brings deep industry insight and practical legal strategy to help your company stay focused and move forward.
Contact Us
Whether you're scaling, fundraising, or navigating FDA pathways, we're here to help. Tell us a bit about your company and we’ll follow up shortly.