From Concept to Clearance—We Guide the Way.

We help medical device and pharmaceutical companies achieve regulatory success across EU MDR, US FDA, and global markets—driving faster approvals, lower compliance risk, and confident international growth.

At Omnee Strategic Solutions, we provide global regulatory consulting and quality system expertise for medical device, pharmaceutical, and biotechnology companies, supporting products across the entire lifecycle—from regulatory strategy, product classification, and FDA pathway planning to technical documentation, conformity assessment, and global regulatory submissions. Our services cover FDA 510(k), PMA, IND, NDA, ANDA, and BLA submissions, EU MDR CE marking, and international market approvals, with proven experience across Class I, II, and III medical devices, pharmaceuticals, and biologics. We integrate ISO 13485, GMP, and GxP-compliant quality systems, risk management, and regulatory intelligence to help companies achieve faster FDA approvals, reduced regulatory risk, and successful global market access. In today’s highly regulated healthcare environment, regulatory compliance and quality excellence are strategic drivers of growth, and we partner with clients to deliver regulatory readiness, operational resilience, and long-term commercial success.




Regulatory & Quality Services

  • Regulatory Strategy Development

    Successfully bringing medical devices and pharmaceutical products to market requires a clear, compliant, and well-defined regulatory strategy. Omnee Strategic Solutions partners with medical device and pharmaceutical companies to develop and execute global regulatory strategies that streamline approvals, reduce regulatory risk, and align with business objectives.

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  • Regulatory Submission Development

    Your innovation deserves a clear path to regulatory approval. Omnee Strategic Solutions provides end-to-end regulatory submission development for medical device and pharmaceutical companies, supporting FDA 510(k), De Novo, PMA, and EU MDR technical documentation, as well as pharmaceutical submissions including IND, NDA, and BLA. Our regulatory expertise helps streamline approvals, reduce compliance risk, and accelerate global market access.

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  • Labelling and Ad-Promo

    What you say about your medical device or pharmaceutical product is just as important as what it does. Omnee Strategic Solutions supports medical device and pharmaceutical companies by ensuring labeling, instructions for use (IFUs), and advertising and promotional materials are clear, accurate, and fully compliant with FDA, EU MDR, and global regulatory requirements.

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  • Post - Market Compliance

    Achieving market approval is only the beginning—maintaining compliance is critical to long-term success. Omnee Strategic Solutions supports medical device and pharmaceutical companies with post-market regulatory compliance, including FDA and EU MDR requirements, to ensure ongoing safety, performance, vigilance, and global regulatory alignment.

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  • Quality Management Systems (QMS) Development & Implementation

    A strong Quality Management System is the backbone of a compliant, efficient, and market-ready organization. Omnee Strategic Solutions helps medical device and pharmaceutical companies design, implement, and maintain audit-ready QMS aligned with FDA QSR/QMSR, ISO 13485, EU MDR, and global regulatory requirements—supporting sustained compliance and operational excellence.

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  • Software as a Medical Device (SaMD) & Digital Health Compliance

    Innovating in digital health is exciting—but navigating the regulatory landscape is complex. At Omnee Strategic Solutions, we help SaMD and digital health companies turn innovative code into compliant, market-ready products across global markets.

    From mobile health apps and AI/ML-based tools to cloud-connected diagnostics, we provide expert regulatory support tailored to the unique challenges of software-driven solutions.

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  • Risk Management & ISO 14971 Compliance

    Risk management isn’t a checklist—it’s a mindset woven into every stage of your product lifecycle. At Omnee Strategic Solutions, we help medical device and digital health companies implement robust, ISO 14971-compliant risk management systems that ensure patient safety, regulatory compliance, and product confidence.

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  • Regulatory Intelligence

    In today’s fast-paced regulatory landscape, staying ahead of changes is key to maintaining compliance and ensuring market success. At Omnee Strategic Solutions, we provide cutting-edge Regulatory Intelligence to help medtech companies navigate evolving global regulations and anticipate changes that may impact your products, operations, and market access.

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  • Regulatory Compliance & Quality Systems Audit Support

    Audits and inspections can determine your ability to enter—and remain in—global markets. Omnee Strategic Solutions partners with medical device and digital health companies to ensure quality systems, technical documentation, and regulatory records are inspection-ready and defensible before global authorities.

    From FDA inspections and EU MDR notified body audits to CDSCO reviews and ISO 13485 certifications, we help you prepare with confidence, respond effectively, and achieve successful inspection outcomes.

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Learn What Our Client Say About Us

Senior Manager, Regulatory Affairs – Large Medical Device Company

“As a client of Omnee Strategic Solutions, I highly recommend their services to help navigate medical device compliance. This firm is knowledgable on US FDA and EU MDR requirements, and has driven excellent results through many regulatory challenges. Regulatory professionals tend to seek resources that can demonstrate current involvement with many regional registration laws; especially when regions are constantly revising regulations. Medical device knowledge of quality system requirements is also very, important. I choose to partner with a group that possesses these strengths. Omnee Strategic Solutions is just that organization. They drives results and have helped me successfully cross many finish lines!”

Chief Executive Officer – Medical Device Start-up

“Navigating my way through the FDA application maze is an insurmountable task, something I not only had no idea as to where to begin or frankly had time for. Omnee Strategic Solutions, was able to navigate through this complicated process with ease and completed my task to get me up and running in quick order. I could have never done it without them!”

Vice President R&D – Midsize Medical Device Company

“Partnering with Omnee Strategic Solutions has been instrumental in our journey towards regulatory compliance and achieving excellence in quality assurance. Their team’s in-depth knowledge and proactive strategies have provided us with invaluable support in navigating complex regulatory landscapes. Thanks to their strategic guidance and meticulous attention to detail, we’ve accelerated product approvals and maintained strict adherence to industry standards. We highly recommend Omnee Strategic Solutions for their professionalism, expertise, and steadfast dedication to our success.”

Chief Executive Officer – Medical Device Start-up

“Working with Omnee Strategic Solutions has been a pleasure. Finding a regulatory professional that is both knowledgeable and business savy is rare. Omnee Strategic Solutions understands how to complete the task at hand in an efficient manner while ensuring that the regulatory requirements are completely met. I have previously worked with over a dozen FDA consultants and none had the regulatory knowledge combined and business acumen that Omnee Strategic Solutions possesses. Under Omnee Strategic Solutions direction and guidance, We received  FDA 510(k) clearance in 3 months and 1 day, which is a remarkable result, while keeping the cost reasonable. We are now working with Omnee Strategic Solutions on further indications and our in-house quality system. Omnee Strategic Solutions offers complete supervision of the FDA process in a cost effective and professional manner, and we could not be more pleased with their services”

Chief Technology Officer – Midsize Medical Device Company

“Working with Omnee Strategic Solutions has been fitting for our company, the young OEM spine device manufacturer. Their expertise in Regulatory Affairs is unparalleled which they drive from many big medical device company experience they have, essentially eliminating the need for our in-house RA department. With Omnee Strategic Solutions guidance, we successfully navigated four FDA 510(k) submissions in the past two years, even challenging the FDA’s perspective and steering them to see through the lens of product developers. Their ability to think with us, and articulate complex product details and regulatory insights into successful submissions has been nothing but pleasant and invaluable.”

Contact Us Today

Fast-track your innovative medical device or pharmaceutical product to market with proven expertise in global regulatory strategy and compliance. Omnee Strategic Solutions supports all classes of medical devices and pharmaceutical products with tailored regulatory pathways, ensuring safe, effective, and compliant market entry across major global markets.

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