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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Ready to equip yourself with first-hand information from our experts? Join us in our new free webinar, “Clinical Trials transition to CTR/CTIS”. All ongoing clinical
During these two interactive days, actors of the healthcare community alongside world experts in biosimilar medicines will gather and debate the evolving biosimilar medicines landscape and emerging trends. Discussion will focus on sharing good practices and setting collective aims to achieve the depth, breadth and speed of the use of biosimilar medicines as a lever to untap their transformative value.
At Asphalion, we are thrilled to announce the opening of our new office in Pamplona! This strategic decision reflects our commitment to being closer to
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Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts.
We will be happy to assist you!
