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Non-clinical safety evaluation of vaccines accelerating clinical development
International Pharmaceutical Industry: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines
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ReadNon-clinical safety evaluation of vaccines accelerating clinical development
Chemistry Today: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines
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ReadSupporting M&As in the pharmaceutical/biopharmaceutical industry
Manufacturing Chemist: At PharmaLex, we believe we have a unique understanding of the cultural challenges experienced during M&As. Having merged ourselves in 2017 into PharmaLex, we have insight in how to overcome the challenges of maintaining agility while benefiting from working in a bigger corporate environment, having economies of scale with an increased resource pool.
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ReadNon-clinical safety evaluation of vaccines accelerating clinical development part II
Manufacturing Chemist: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines
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ReadNon-clinical safety evaluation of vaccines accelerating clinical development part I
Manufacturing Chemist: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines
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ReadCan a robust QMS help you achieve customer satisfaction?
PharmaLex.pert Limaris Alvarado discusses the part quality management systems (QMS) play in ensuring companies continually enhance customers’ experience and satisfaction?
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ReadProduct Launch
PharmaLex.pert Limaris Alvarado discusses the complexities of product launch and the importance of effective planning, efficient manufacturing process, technical capability, regulatory strategy, and committed launch date strategy.
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ReadComplying Confidently? Learning Lessons from Nitrosamine Impurities
PharmaLex.pert Diego Martinez discusses why industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established.
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ReadDrug Development Decisions
Zeb Younes & Zaklina Buljovcic will give you insightful information about new approaches to Drug Development. This article is taken from the European Biopharmaceutical Review October 2019, pages 58-64. © Samedan Ltd.
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ReadEMA simplifies the process for internal transfer of MAs
PharmaLex Vice President Regulatory and Scientific Policy, Jonathan Trethowan discusses how the EMA’s simplified process for internal transfer of marketing authorizations may help some Brexit Impacted MAHs.
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ReadArtificial Intelligence in drug development: What are current use cases? - Part 2: Pharmacovigilance
PharmaLex CEO, Tilo Netzer looks at the opportunities for AI in drug development, examining the use cases in relation to pharmacovigilance
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ReadThe Pink Sheet - Big Data: Moving From Artificial Trials To A Smarter Regulatory Process
PharmaLex’s Bruno Boulanger discusses the impact big data will have on how the pharmaceutical industry gathers and delivers data in the future. *subscription required*
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