Full Service CRO for Medical Device Global Entries.

Our global CRO business stands as a beacon of innovation and reliability. With a focus on precision, efficiency, and foresight, we are committed to revolutionizing the journey of medical device market entry through the seamless integration of strategic consultancy and unparalleled industry proficiency.

Regions we focus on

FDA Compliance

Navigating the regulatory landscape of the United States is paramount, and Mecca excels in meeting the rigorous standards set by the FDA. Our Regulatory Affairs team has extensive experiences in FDA requirements, ensuring that your medical devices not only meet but exceed the expectations of this gold standard regulatory body.

CE Mark

For market access in the European Union, our Regulatory Insights experts facilitate the CE marking process. We understand the intricate requirements and nuances of European regulations, and our team ensures that your medical devices comply with the essential health and safety requirements. Mecca acts as your strategic partner, guiding you through the CE marking journey with precision and expertise.

NMPA Compliance

In the dynamic healthcare market of China, adherence to NMPA regulations is critical. Mecca's Regulatory Affairs department is adept at navigating the evolving regulatory landscape in China, ensuring that your products gain swift approval and maintain compliance with NMPA standards. We facilitate the integration of your medical devices into the Chinese market seamlessly.

Global Reach

Mecca goes beyond the major regulatory bodies, extending our expertise to encompass global markets. Our Regulatory Insights professionals are well-versed in the regulatory requirements of numerous countries, fostering compliance and market access worldwide. Whether it's the Therapeutic Goods Administration (TGA) in Australia or other regulatory authorities, Mecca is your trusted partner for global regulatory success.