Compliance
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Facilities | Inspections | QA/QC | Regulatory Affairs
Are Indian Generic Firms Improving Compliance?
Indian firms take the generics battle to U.S. turf.Online Exclusives S. Harachand, Contributing Editor 08.09.18
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Drug Development | Regulatory Affairs
Why Otsuka Outsourced Regulatory Affairs
How outsourcing regulatory affairs gave Otsuka flexibility to move products through the development process faster.Online Exclusives Kristin Brooks, Managing Editor 08.09.18
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Bio News | cGMP Manufacture | Facilities | Industry News | Inspections
Absorption Systems' ACF Bioservices Certified by MHRA
Certification warrants that facility is in compliance with the cGMP requirements after an April 2018 inspection by the MHRA08.07.18
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Bio News | Biologics, Proteins, Vaccines | QA/QC
Avalon GloboCare Forms Strategic CAR-T Pact
Aims to co-develop bio-production and standardization procedures for CAR-T therapy in accordance with standards08.07.18
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Collaborations & Alliances | Regulatory Affairs | Serialization
Abdi Ibrahim Selects rfxcel for FMD Compliance
Will support serialization software to ensure compliance with current & future international legislative requirements08.02.18
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APIs | Bio News | Facilities | Industry News | Inspections
WuXi STA Site Passes Fourth Inspection
API manufacturing facility at Jinshan also passed FDA inspection in 2013, 2014 and 201607.26.18
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Regulatory Affairs
Elemental Impurity & Risk Assessment
An update on the retirement of USP General Chapter <231>.Paul Mason, Lachman Consultants 07.20.18
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Industry News | Promotions & Moves | Regulatory Affairs
Slayback Appoints Global Affairs SVP
Joan Janulis is also a noted speaker at various FDA/Industry conferences07.17.18
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Aseptic Processing | Formulation Development | Information Technology | Logistics | QA/QC
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Clinical Trials | Drug Development | Regulatory Affairs
Are EMA-Style Rules for First-in-Human Trials Coming to North America?
Insights from the 2018 DIA Global MeetingBeatrice Setnik, Ph.D., Vice President, Scientific and Clinical Strategy, Early Phase, Syneos Health 07.03.18
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Bio News | GMPs/GCPs | Industry News | Regulatory Affairs
MHRA Grants MeiraGTx Manufacturer’s Authorization
Enables the manufacture of gene therapy product candidates in current cGMP compliant facility06.21.18
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cGMP Manufacture | Industry News | Regulatory Affairs
Samsung BioLogics Licensed by Health Canada
To manufacture a monoclonal antibody drug substance at its first plant06.21.18
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cGMP Manufacture | Facilities | Industry News | Inspections
Umicore API Facility Passes cGMP Audit
The plant manufactures four oncology APIs produced for global markets according to the latest international guideline06.20.18
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CRO News | Industry News | Promotions & Moves | QA/QC
TFS International Appoints Quality Assurance EVP
Dr Suzanne Pavon brings over 20 years’ global experience in the CRO, biotechnology and pharmaceutical industries06.20.18
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APIs | Breaking News | Collaborations & Alliances | Industry News | Process Validation | Regulatory Affairs
WuXi STA Enables Ascletis to Receive NDA Approval from China FDA for Ganovo
Is first CDMO to support the approval of an innovative drug in China through the MAH pilot program06.14.18
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Regulatory Affairs | Solid Dosage/Creams/Ointments
Semi-Solid Dosage Forms
Compliance of semi-solid dosages to FDA Stage III Continuous Process VerificationJosé L. Toro, Ph.D., Lachman Consultants 06.12.18
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Inspections | Regulatory Affairs
PAI Readiness – A Journey, not an Event
A look at what you need to do to get ready for a pre-approval inspectionDr. Walter Matzmorr, Tunnell Consulting 06.12.18
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QA/QC | Regulatory Affairs
The Outsourcing Balancing Act
Achieving the best blend of oversight and involvementLeona Fitzgerald and Denise Moody, PPD 06.12.18
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cGMP Manufacture | Industry News | Inspections
Pii Gets Positive Inspection News from FDA and MHRA
Previously restricted GMP Certificate withdrawn based on recent inspections by the FDA06.11.18
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Bio News | cGMP Manufacture | Industry News | Regulatory Affairs | Risk Management
Stellar Announces Positive Third-Party Trial Results
The company's KLH manufacturing methods have achieved robust viral clearance05.29.18
