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US REGULATORY STRATEGY

Donawa Lifescience Consulting (DLC) understands the processes available to pharmaceutical manufacturers that need to be followed before a new drug can be placed on the US market.

Our pharmaceucital regulatory specialists have many years’ experience in assisting early stage companies navigate the sometimes complex regulatory pathways, in order to identify the most appropriate regulatory strategy and achieve marketing clearance in as short a time as possible.

DLC can act on your behalf in discussions with FDA to obtain informal opinions on likely product status. For innovative products, this is sometimes best done without revealing the client company name to FDA.

Once the best compliance route has been identified, we can help maintain contact with FDA throughout the approval process and assist with development of the submission.

If you are a small business, we can help you request small business status with FDA in order to achieve significant discounts on application fees.

Please contact us to learn more.