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, due to the implementation by the FDA of 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: [email protected]
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Seamless Regulatory Submissions Meeting Global Standards
Test your Regulatory knowledge!! The summer is back and, for a 4th year in a row, so is Asphalion’s classic ASPHAQUIZ on LinkedIn, our daily
On 18th June 2024, a new version 3.1 of the EU eCTD M1 specification was published on the eSubmission website, marking a significant milestone in
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As a company committed to sustainability, we follow the UN’s 2030 Agenda and its Sustainable Development Goals.
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