Effective Medical staff comprise of industry-experienced professionals who have spent many years working in-house at Top 10 pharma companies and who have extensive experience of reviewing and interpreting regulatory questions and compiling comprehensive and detailed responses. Scientifically credible and accurate documentation is essential in these circumstances to ensure effective communication between healthcare companies and regulatory authorities. Whilst prevention with comprehensive clinical submissions and robust signal detection processes are better than resolving after the fact, if questions do arise it is essential to understand what is being asked and respond appropriately failure to provide acceptable answers can lead to distrust from a regulator and costly delays in approvals. ![]() ![]() Questions relating to the safety of a medicinal product or device can arise at any time or can be anticipated in advance at the time of regulatory activity (i.e.
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