Are you planning to send a submission to the FDA?
Will this submission contain study data?
If the answer to these 2 questions has been yes, this brochure may be of your interest, since last year the FDA implemented the Technical Rejection Criteria (TRC) for Study Data by CDER and CBER.
Have a look at this brochure for an overview in detail:
For further information, you can contact us at: info@asphalion.com
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Have a look at a recent success story of how Asphalion helped a local company expand its business internationally, helping it create a growth strategy
MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners.
The new recognition routes open additional options for the MHRA to bring cutting-edge medicines faster to UK patients by leveraging the expertise and decision-making of trusted regulatory partners.
The event is taking place at São Paulo Expo from 23 to 26 of May, 2023.
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