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US LIAISON WITH FDA
With former FDA officials and field inspectors among our staff and associates, Donawa Lifescience Consulting (DLC) is well-positioned to help pharmaceutical companies communicate with FDA.
Sometimes it is beneficial for initial contact with FDA to be made without identifying the client company involved. DLC can act on behalf of the client in these initial communications to establish the regulatory pathway most likely to lead to market availability in the shortest timeframe.
If requested, DLC can arrange pre-IND meetings with FDA and either attend as representative of the client or support attendance by company staff.
Once the most appropriate route has been established, DLC can maintain communication with FDA as the submission progresses, allowing early feedback to the client if any questions arise, or additional data is requested.
We can also help in the structuring and content of your application, review your file prior to submission, and help with any administrative issues with FDA.
Please contact us to see how we may be able to help.
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