Compliance

QA/QC | Regulatory Affairs

Regulatory Compliance Trends

Re-assessing outsourcing strategies for ‘new normal’ regulatory compliance.

Steve Cottrell, President, Maetrics 10.14.20

Breaking News | Industry News | Inspections

Symbiosis Completes MHRA Regulatory Inspection

Scottish CMO recorded no critical or major observations from the reinspection by the MHRA.

Contract Pharma Staff 10.13.20

Breaking News | cGMP Manufacture | Industry News | Parenterals | QA/QC

Lonza Expands QC Testing Portfolio

Launches PyroCell MAT System for in vitro Pyrogen testing to help ensure safety of parenteral pharmaceuticals during development, manufacture and release.

Contract Pharma Staff 10.01.20

Biologics, Proteins, Vaccines | Regulatory Affairs

Ensuring Manufacturing Continuity for Essential Medicines

Applying the principles of Quality Risk Management to get medicines to market faster.

John Darby, M.Sc., Senior Director, Lachman Consultant Services, Inc. 09.09.20

Inspections

Virtual Site Audits Should Be the New Standard

Discovering the value of virtual site audits during the COVID-19 crisis.

Jeannie Metzinger, PCI Pharma Services 09.09.20

Biologics, Proteins, Vaccines | Drug Development | Regulatory Affairs

Expediting a COVID-19 Vaccine: FDA Approval Process

The pressures of the pandemic are pushing sponsors and FDA to look at both efficacy and speed in developing a vaccine.

Kristin Brooks, Managing Editor 09.09.20

LSNE Expands Aseptic Fill Finish Capabilities in Europe

LSNE-León receives approval from AEMPS to manufacture biotechnology-based therapeutic products.

Contract Pharma Staff 08.28.20

Biologics, Proteins, Vaccines | Drug Development | Regulatory Affairs

Expediting a COVID-19 Vaccine: FDA Approval Process

The pressures of the pandemic are pushing sponsors and FDA to look at both efficacy and speed in developing a vaccine.

Online Exclusives Kristin Brooks, Contract Pharma 08.25.20

Breaking News | Facilities | Industry News | Inspections

FDA Approves Romark Facility in Puerto Rico

The facility is equipped to produce tablets, powders and other oral solid dosage forms.

Contract Pharma Staff 08.24.20

Breaking News | Industry News | QA/QC

Rx-360 Expands Audit Program

Adds remote auditing and new checklists.

Contract Pharma Staff 08.12.20

APIs | Clinical Trial Materials | Process Validation | QA/QC | Regulatory Affairs

Regis Custom Pharma

07.31.20

Drug Development | GMPs/GCPs | Information Technology | QA/QC

Solving Compliance Challenges and Beyond with Natural Language Processing

Understanding new data sources and elevating compliance to drive innovation.

Updesh Dosanjh, Practice Lead, IQVIA Vigilance Platform, IQVIA, Jane Reed, Head of Life Science Strategy, Linguamatics, an IQVIA company 06.16.20

Drug Delivery | Regulatory Affairs

Regulatory Overhaul for Medical Devices

Implications for the pharmaceutical industry.

Elizma Parry, Director, Global Clinical Practice, Maetrics 06.04.20

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 compliant

Contract 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 pandemic

Contract Pharma Staff 05.13.20

Information Technology | Regulatory Affairs

Data Integrity: Beyond Electronic Records

Get your Data Integrity house in order

Tim 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 Act

Contract 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