Responding to regulator safety enquiries
When regulatory authorities have questions about the safety of your products you had better be able to come up with the answers. And who better to help with the response than PrimeVigilance experts and consultants who have “sat on the other side of the table”?
We can help interpret the questions, identify the necessary resources for the response, develop the strategy and contribute to, write or review and comment on the response document. PrimeVigilance consultants can help companies prepare with pre-hearing rehearsals, or attend and support during oral representations with the regulators.
Inadequate responses can result in unnecessary damage to products and the reverberations can result in a vicious cycle of continuing questions and responses.
But prevention is better than cure and early identification of potential safety concerns and their effective management, assisted by PrimeVigilance consultants, may help to pre-empt the regulators’ questions. And we can help you put in place the necessary crisis management procedures just in case those difficult questions do arise.
Methods and Pitfalls in Searching Drug Safety Databases Utilising the Medical Dictionary for Regulatory Activities (MedDRA). Leading article. Brown EG Drug Safety 2003, 26(3):145-58.
Regulatory Authority Liaison: Compliant and Expert
For more information contact PrimeVigilance today