Compliance
-
Drug Development | Industry News | QA/QC
USP Provides Guidelines for rFC Reagent
Recombinant Factor C critical to development of vaccines and other sterile pharmaceutical products.Contract Pharma Staff 06.01.20
-
Breaking News | Facilities | Industry News | Inspections
PharmaCyte Conducts Final Audit of Mfg. Facility
Batch records in Thailand have been deemed cGMP compliantContract Pharma Staff 05.18.20
-
cGMP Manufacture | CRO News | QA/QC
Parexel Launches COVID-19 Risk Mitigation Offering
Four-step methodology aims ensure manufacturers can safely continue manufacturing operations through the COVID-19 pandemicContract Pharma Staff 05.13.20
-
Information Technology | Regulatory Affairs
Data Integrity: Beyond Electronic Records
Get your Data Integrity house in orderTim Rhines, Ph.D., Director, Lachman Consultant Services, Inc. 05.05.20
-
Industry News | Regulatory Affairs
FDA COVID-19 Update
Issues guidance highlighting flexibility under the Drug Supply Chain Security ActContract Pharma Staff 05.01.20
-
cGMP Manufacture | GMPs/GCPs | Inspections | Regulatory Affairs
FDA cGMP Inspections Amid COVID-19 Pandemic
Despite FDA's postponement of most facility inspections, the pharma manufacturing industry should be prepared for heightened scrutiny as this crisis develops.John J. Carney, Lee H. Rosebush, Susrut A. Carpenter, Andrew M. Serrao, BakerHostetler 04.22.20
-
Drug Development | GMPs/GCPs | Regulatory Affairs
FDA’s Emergency Use Authorizations
Aggressive Action Taken to Combat COVID-19Chad Landmon and Drew Hillier, Axinn, Veltrop & Harkrider LLP 04.20.20
-
Breaking News | Clinical Trials | CRO News | GMPs/GCPs
Advarra Acquires IRB Company, Inc.
Expands presence of integrated IRB services in North America.Contract Pharma Staff 04.20.20
-
Bio News | Breaking News | Industry News | Inspections
WuXi Biologics Passes EMA GMP Inspection
Suzhou site clears regulatory hurdle with not critical findingsContract Pharma Staff 04.15.20
-
Clinical Trials | Information Technology | QA/QC
Managing Clinical Trials Amid the Coronavirus Pandemic
Patrick Hughes of CluePoints discusses the impact on clinical trials and how leveraging data may herald a long overdue paradigm shift in the industry.Online Exclusives Kristin Brooks, Contract Pharma 04.06.20
-
Regulatory Affairs
Inquiring Minds Want to Know, Just Ask FDA
What you need to know prior to submissionMichelle Ryder, Lachman Consultant 04.01.20
-
Breaking News | Industry News | Packaging & Tracking | Regulatory Affairs | Solid Dosage/Semi-solids
Novartis Recalls Sandimmune, Neoral Blister Packs Due to Packaging Failure
Corrective action plan to address blister packs that do not meet U.S. child-resistant packaging requirements, there are no quality or efficacy issues.03.19.20
-
Breaking News | Industry News | Inspections | Regulatory Affairs
COVID-19 Update: FDA Scales Back Domestic Inspections
Temporarily postpones all domestic routine surveillance facility inspections, for-cause inspections will be evaluated and will proceed if mission-critical.03.19.20
-
Breaking News | Industry News | Inspections | QA/QC | Regulatory Affairs
COVID-19 Update: FDA Foreign Inspections
To postpone most foreign inspections through April, effective immediately03.10.20
-
Breaking News | Industry News | Inspections
-
Regulatory Affairs
The Art of Filing NDA/ANDA Post-Approval Changes to the FDA
Some tips to make your trip along the regulatory pathway to report manufacturing changes easier.Amy Schutte, Senior Associate, Lachman Consultant Services 03.04.20
-
Breaking News | Industry News | Inspections | QA/QC | Regulatory Affairs
FDA Provides Update on Activities Related to Coronavirus
Says it continues to monitor the global drug supply chain by prioritizing risk-based inspections in other parts of the world02.25.20
-
Breaking News | Industry News | QA/QC
ALKU Expands Services to Focus on Analytical R&D
Expands services into two groups, Pharmaceutical Quality, Validation, and Compliance, and Pharmaceutical Analytical Research and Development02.21.20
-
Breaking News | Industry News | Information Technology | Validation
ValGenesis Digitizes Validation Lifecycle Process
Across multiple sites for a global CDMO based in southern Europe02.13.20
-
Breaking News | Industry News | Inspections
