Smarter pathways to market approval
Clinical and Regulatory Success
Whether you need full-service clinical trial management or à la carte consulting, we’re here to move your program forward with precision, flexibility, and results.
Since 2016, Nilo Medical Consulting Group, LLC has partnered with medical device, pharmaceutical, and biotechnology companies to deliver trusted regulatory consulting and clinical research services. From early concept development to global market entry, we support innovators across every stage of the product lifecycle — whether you're designing, manufacturing, or preparing for commercialization.
Our experienced team provides strategic and hands-on support for:
Clinical trial design and execution
Global regulatory submissions and agency interactions
Product development and quality systems
Comprehensive CRO services including monitoring, safety oversight, and data management
Specialized medical writing and reimbursement strategy
Our Services
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Regulatory
Expert guidance through every stage of regulatory strategy and submissions. We prepare 510(k), De Novo, PMA, IDE, and global submissions, facilitate FDA interactions, and secure designations such as Breakthrough Device and STeP.
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Clinical
Full-service CRO support for efficient, compliant clinical trials. From protocol design and site management to monitoring, data oversight, and study reporting, we ensure trials run smoothly and meet regulatory requirements.
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Quality
Comprehensive quality system development and support. We create and optimize QMS frameworks that meet 21 CFR 820 and ISO 13485, manage risk under ISO 14971, and prepare teams for audits, inspections, and post-market requirements.
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Product
Strategic support across the product lifecycle. We help with design controls, risk management, usability and human factors, verification and validation planning, and regulatory-aligned development to bring safe, effective products to market.
“Nilo Medical Consulting Group provides unparalleled expertise and guidance in the healthcare industry. Their team's deep understanding of medical regulations and emerging trends ensures we receive top-tier consultation tailored to our needs at LiViliti Health Products. I highly recommend NMCG for their professionalism, knowledge, and dedication to client success.” (CEO, LiViliti)