AllCells’ Post

https://lnkd.in/grtNQi6h Discover the importance of flexibility with CGT Global’s cryopreserved leukopaks! Our GMP Laboratory allows you to customize your product order into separate bags, ensuring you can thaw only what your project requires, minimizing waste, and allowing for the reproducibility of your research and clinical projects.. Contact us today to learn more. #CGTglobal

Are you ready to elevate your Annex 1 knowledge? make sure to pop by the Cencora PharmaLex stand at the ISPE event on Annex 1 in Waterford today. Meet our expert Patrick Nieuwenhuizen who is available to answer any questions you may have. See you at our stand! #CencoraPharmaLex #ISPEEvent #Annex1 #PharmaceuticalIndustry #RegulatoryAffairs #QualityCompliance #Networking #Innovation

Wrapping up two days of the "Challenges and Advanced Solutions for Aseptic Processes & Barrier Systems" event successfully brought together industry leaders, experts, and practitioners to explore the current challenges and innovative solutions in aseptic processing. Over those two days, participants gained valuable insights into regulatory requirements, technological advancements, and practical implementation strategies. The discussions and interactions have not only highlighted the importance of continuous improvement and adaptation in aseptic processes but also underscored the need for collaboration and knowledge sharing within the industry. As we look to the future, the event has set a solid foundation for ongoing innovation and excellence in aseptic processing, ensuring safety, efficiency, and sustainability remain at the forefront of industry practices. Many thanks to PDA Italy Chapter for the great organization, IMA Group for hosting this event, and Fedegari Group to let me participate as an active speaker. Thanks to AIFA Agenzia Italiana del farmaco for the presence as regulatory representative #sustainableInnovations

Dec 2023 - MDCG 2023-6 - Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodies - December 2023 Source: https://lnkd.in/dGs6emhr #eudamed #medtech #medicaldevices #regulatoryaffairs #regulatorycompliance #EUDAMED 

Cosmetic Quality Leaders: ready for MoCRA's GMP requirements? Register for NSF's webinar on NSF/ANSI 455-3 Cosmetic GMPs to get ahead of the new regulatory environment. #MoCRA #GMPs #455-3 #Cosmetics

#RegulatoryUpdate ICH Adopts M13A Guideline on Bioequivalence Testing. The International Council for Harmonisation (ICH) recently adopted its M13A guideline, which aims to harmonize the framework for assessing the bioequivalence (BE) of immediate-release (IR) solid oral dosage forms and assessing BE after post approval changes. The guideline aims to eliminate the need for sponsors to conduct additional BE studies due to divergent regulatory requirements to support marketing authorizations in different jurisdictions. Additionally, the guideline covers BE study designs, including study populations, study designs, the test and comparator products, fasting and fed study conditions, the dose or strength to be studied, and the moieties to be measured. This shall come into effect on January 25th 2025.   Read More: https://lnkd.in/dZZvTzED #RegulatoryHarmonisation

Cosmetic Quality Leaders: ready for MoCRA's GMP requirements? Register for NSF's webinar on NSF/ANSI 455-3 Cosmetic GMPs to get ahead of the new regulatory environment. #MoCRA #GMPs #455-3 #Cosmetics

Dec 2023 - MDCG 2023-5 - Guidance on qualification and classification of Annex XVI products A guide for manufacturers and notified bodies  Source: https://lnkd.in/dN9kj2nJ #eudamed #medtech #medicaldevices #regulatoryaffairs #regulatorycompliance #EUDAMED 

Cosmetic Quality Leaders: ready for MoCRA's GMP requirements? Register for NSF's webinar on NSF/ANSI 455-3 Cosmetic GMPs to get ahead of the new regulatory environment. #MoCRA #GMPs #455-3 #Cosmetics

Dec 2023 - MDCG 2023-6 - Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodies - December 2023 Source: https://lnkd.in/dPmsSrt6 #eudamed #medtech #medicaldevices #regulatoryaffairs #regulatorycompliance #EUDAMED