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01.26.21 -- Top 10 Most-Cited MHRA GMP Inspection Deficiencies - Vimarsana News

01.26.21 -- Top 10 Most-Cited MHRA GMP Inspection Deficiencies

01.26.21 -- Top 10 Most-Cited MHRA GMP Inspection Deficiencies   Continuing our Cell & Gene series, Business of Biotech features Dr. Bobby Gaspar, Orchard Therapeutics CEO, speaking on the challenges his company faces in the production of hematopoietic stem cells to treat neurometabolic disorders, primary immune deficiencies, and blood disorders. Listen now and subscribe so you never miss an episode. Featured Editorial By Barbara Unger, Unger Consulting Inc. In Part 1 of this two-part article, we evaluated the U.K. Medicines and Healthcare products Regulato...

01.07.21 -- Facility Engineering, Design, And Construction Tips For Up-Start Biotech Companies - Vimarsana News

01.07.21 -- Facility Engineering, Design, And Construction Tips For Up-Start Biotech Companies

01.07.21 -- Facility Engineering, Design, And Construction Tips For Up-Start Biotech Companies     This report helps small and emerging biopharma companies make more informed CMO decisions, and helps CMOs optimize operational and marketing strategies to better accommodate this segment. Findings are based on 93 service encounters from 42 respondents involved in outsourced small molecule API projects in the past 18 months. Learn more here. Featured Editorial By Herman F. Bozenhardt and Erich H. Bozenhardt Fledgling biotech companies are financially fragile, a...

12.17.20 -- FDA FY2020 Drug Inspection Observations And Trends - Vimarsana News

12.17.20 -- FDA FY2020 Drug Inspection Observations And Trends

12.17.20 -- FDA FY2020 Drug Inspection Observations And Trends   ISR’s Health Panel includes managers, directors, executives, and subject matter experts in clinical development and drug manufacturing who work at pharma companies, service provider companies, and research sites. Members are paid for their time (a 15-minute survey may pay $40, whereas a 45-minute phone interview may pay $150) and they get to choose which research opportunities to participate in. Apply here. Featured Editorial   This article presents the FDA's most recent publication of GMP ...