Navigating US Market Entry for Non-US Manufacturers

I’m traveling in Southeast Asia for a series of meetings with pharmaceutical companies that operate manufacturing facilities across the region and are interested in entering the US market.

Beaufort supports organizations considering this type of business expansion by providing a top-down gap assessment of their facility’s current manufacturing processes, targeting alignment with cGMP. The output of our review will identify gaps that can be corrected either through staff training and process improvement or if there is a need for greater capital / infrastructure investment. Ultimately, Beaufort’s strategic analysis details the scope and scale of business investment needed to meet the requirements for US market entry.

Senior Vice President and Chief Quality Officer at Beaufort John R. Wilson Jr., Ph.D.
John R. Wilson Jr., Ph.D.
Senior Vice President and Chief Quality Officer

All GMP standards implemented worldwide require manufacturers to adhere to minimum standards throughout the entire production process. However, understanding the similarities and differences between non-cGMP and cGMP requirements is critical.  Our team is skilled at identifying and reporting on deviations across all areas, including facility design and maintenance, equipment design and validation, Quality Risk Management (QRM) systems, Quality Management Systems (QMS), process validation, SOP implementation, as well as documentation and record keeping.

Reach out to Beaufort if you are a pharmaceutical manufacturer interested in evaluating US market entry strategies and need a team of experts that can review, assess, and ensure compliance with cGMP.

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