Global Regulatory Strategy

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Our In-Country Authorized Representative service ensures that your company maintains a trusted local presence to meet regulatory requirements in international markets. 

Acting as your official liaison with government authorities, we manage compliance communications, product registrations, and regulatory submissions on your behalf. This service provides peace of mind by ensuring your business remains aligned with local laws, while enabling smooth market entry and sustained global operations. 

Our Country Legalizations service ensures that your corporate and product documents meet the official requirements for recognition in international markets. 

We manage the legalization process from start to finish—coordinating with government authorities, embassies, and consulates to certify documents for cross-border use. By streamlining complex procedures and ensuring accuracy, we help businesses achieve smooth market entry, maintain compliance, and operate confidently worldwide.

Our Jurisdictional Labeling and Unique Device Identification (UDI) services ensure that your medical devices meet country-specific labeling requirements while maintaining global compliance standards. 

We manage the complexities of adapting product labels to local regulations and oversee accurate UDI submissions to the FDA and other authorities. By streamlining these processes, we help manufacturers achieve transparency, traceability, and market readiness across multiple jurisdictions.

Our Certificate of Foreign Government service helps manufacturers obtain official documentation from the U.S. Food and Drug Administration confirming that the products are legally marketed in the United States. This certificate is required by foreign regulatory authorities to approve imports and ensure compliance with local laws. 

We streamline the application, prepare a submission, and coordinate directly with the FDA, giving your business the tool needed to expand into international markets.

The PRRC service provides organizations with a designated expert to oversee regulatory compliance, ensuring that medical devices and related products meet all applicable requirements under EU MDR, IVDR, and other global frameworks. 

Acting as your official compliance representative, the PRRC manages documentation, monitors regulatory obligations, and serves as a point of contact for authorities.  

Our Export Regulatory Submission service ensures that your products meet all international regulatory requirements before entering foreign markets.

 We manage the preparation and submission of documentation to global authorities, aligning with country-specific standards and FDA guidelines. From certificates and compliance records to technical dossiers, our team streamlines the process to reduce delays and minimize risk. With expert oversight, your business can expand confidently.