Emprove® Press Releases
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Cloris Tian, Senior Regulatory Manager, APAC, Shanghai, China, and Yuwei Heinzel, Head of Pharma Registration Germany, Merck KGaA, Darmstadt, Germany on: Chinese Excipient Regulation – a Globally Unique Challenge |
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Frithjof Holtz, Advocacy & Surveillance, Life Science Regulatory Management, Merck KGaA, Darmstadt, Germany on: EU Excipient Risk Assessment Guidelines – Practical Implementation Experience |
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Satish Kumar Mohanvelu, Marketing Manager, Emprove® Program, MilliporeSigma, Jessica Shea, Global Technical Support, on: The Role of BPOG Extractables Data in the Effective Adoption of Single-Use Systems |
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Douglas Bowman, Program Manager, Emprove® Program, on: Identifying Appropriate-Quality Raw Materials in an Evolving Regulatory Environment |
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Janmeet Anant, Regulatory Advocate, on: Risk Assessment for Single-Use Pharmaceutical Manufacturing Systems |
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Janmeet Anant, Regulatory Advocate, on: Biosimilars: Regulatory Trends and Manufacturing Considerations |
Dr. Ulrich Reichert, Head of Pharma & Food Materials, Regulatory Management, on: Elemental Impurities: Implications for Manufacturers of Drug Products, APIs, and Excipients, published in American Pharmaceutical Review |
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PDA Letter Frithjof Holtz, Head of Advocacy and Surveillance for Regulatory Management, on: Establishing a Formalized Risk Assessment for Excipients |
European Pharmaceutical Manufacturing Heike Michaelis, Director of the Emprove® program, and Frithjof Holtz, Head of Advocacy and Surveillance for Regulatory Management, on: Risky business: Establishing quality risk assessments |