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.