The new European Clinical Trial Regulation came into force on 31 January 2022.
To help companies better prepare themselves for the transition, we prepared a white paper where our CMC experts highlighted the notable changes in the new CTR impacting CMC activities.
Did you know that…
- CTR results in stricter timelines in general and particularly for CMC
- Changes were made in view of quality (oversight)?
- New definitions are introduced (AxMP, …)?
In case any of these questions you answered NO, feel free to contact us(BD@2Bridge.be) and let us support your upcoming or ongoing clinical trials in Europe! The CMC team at 2 Bridge consists of experts in multiple domains of CMC, all passionate and motivated to contribute to the success of our Tiger Teams. We have Product Development leads, Clinical Supply Management experts, CMC Regulatory experts, GMP/GxP Quality Experts, and European Qualified Persons on our team.
We are ready for the challenge. Are you?
To read the full white paper, please click here: CTR Impact on CMC_WP_final_2023