Going nowhere fast?

No Orient express here.  We were approached by a European Multinational exporting surgical dressings to China.  One of their submissions for a Class III dressing had been stalled in the review process for more than a year.  Brandwood Biomedical took on responsibility for the submission.  Our Beijing leadership were able to communicate directly with CFDA to identify the issues which were preventing completion of the review, negotiate a straightforward solution and expedite supply of the required information to the agency.  The submission then proceeded smoothly and was approved a short time later.

The lesson.  If your submission appears to have stalled, don’t wait around hoping.  Our experts have a deep knowledge of the regulatory submission requirements.  We can communicate at the right level with regulators to identify the problem and reach a solution.


Help button-Quick Call-Brandwood BiomedicalStruggling with a current submission- or just don’t know where to start? We can help you with developing your evaluation strategy, dealing with test laboratories and preparation of expert reports.

Contact us to discuss your needs and how we can help. You can drop us an Email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)

 

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