EMA guidance for ATMP

At the end of 2021, EMA published very useful flowcharts and checklists on navigating the development of advanced therapy medicinal products (ATMPs). As we believe this EMA guidance for ATMP contains which could be very useful to our ATMP customers and audience we gladly share this with all of you.

Find all flowcharts and checklists on the EMA website: https://www.ema.europa.eu/en/human-regulatory/overview/advanced-therapy-medicinal-products-overview

As presented by Charlotte Bakker on the 29th of November 2021. During the webinar: EMA and EATRIS present: Navigating the Regulatory Requirements for ATMPs. EMA guidance for ATMP

How Medace supports ATMP development

Next to our cleanroom facilities, we support our clients extensively during the regulatory and quality trajectory. For example, we support during communication with the national and European competent authorities Additionally, we support the subsequent application for the necessary classifications and licenses. You can the article on the classification by EMA on the product of our client InoCells below.

Clients are also guided in how to set-up their technical dossier and QMS required for clinical validation. We have an overarching QMS in place, offer  dedicated training programs and have an team of trained professionals for hands-on guidance and support. The Medace approach, infrastructure and QMS are certified according to the latest standards and compliant to the pharmaceutical guidelines.

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We offer start-ups and researchers flexible access to our 2,000 m2 R&D and Cleanroom facilities to enable them to perform development and clinical-grade production of their product when needed. Interested in seeing the facilities? Do the virtual tour: https://www.medacespace.com/facilities/