When companies need expert help in Regulatory Affairs, they come to Clinlogix. With over 20 years of experience in medical devices, pharmaceuticals, diagnostics, and emerging fields of medicine, Clinlogix has guided companies through the finish line of an often-complicated regulatory process.

As the regulatory environment can be capricious, even more so with a novel product, we understand the challenges before you may seem endless. Integrated as a part of your team, Clinlogix will work side by side with you throughout the entire process.

With our strategic thinking and effective negotiation and communication skills, our consulting services navigate complicated regulatory nuances so that our stakeholders know how to manage their compliance risks, be safe, and make an impact on patients, public health and their company’s bottom line. Not only will we develop and execute an efficient regulatory compliance strategy, but we will also ensure your regulatory and compliance risk mitigation strategies are robust.

Our commitment to success begins with the local teams we have in place. Our in-depth regulatory knowledge on the local and global scale is backed by experts who have worked with the U.S. Food and Drug Administration (FDA),  European Medicines Agency (EMA), and The Colombia National Food and Drug Surveillance Institute (INVIMA) for decades and is an asset your company can count on. They are intimately familiar with the specific regulations, guidelines, and product standards for development and collaborate closely with local, state, and federal regulatory agencies to help refine best practices and harmonize regulations.

Whether it is a smaller consulting role, or a full-scale regulatory application submission, Clinlogix has solutions to match your specific needs. Backed by a proven track record of highly successful product applications to regulatory agencies globally, we are at the ready to serve you.

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Regulatory Services

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