Compliance

Breaking News | Drug Development | Industry News | Information Technology | Regulatory Affairs

Top BioPharma Form Accumulus Synergy

Aims to develop a cloud-based Global Data Sharing Platform to facilitate data and information sharing between industry and health authorities worldwide.

Kristin Brooks 01.22.21

Breaking News | Industry News | Information Technology | Validation

Global Biosciences Co. Selects ValGenesis VLMS

Will digitize the validation service activities for efficient and faster access to validated and safer products across 40 countries.

Contract Pharma Staff 01.20.21

Breaking News | Industry News | Information Technology | Validation

Gene Therapy Co. Selects ValGenesis' SaaS Platform

VLMS to digitize Its global validation programs.

Contract Pharma Staff 01.06.21

Drug Development | Industry News | Regulatory Affairs

The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to "normalcy".

Chad Landmon, Michelle Divelbiss and Alex Alfano, Axinn, Veltrop & Harkrider LLP's Intellectual Property and Food and Drug Administration Practice Groups 01.05.21

CDMO Cognate BioServices Teams Up with L7 Informatics

To implement L7|ESP for integrated manufacturing and lab operations.

Contract Pharma Staff 12.16.20

Samsung Biologics Adopts Veeva Vault QMS to Unify Quality Management

CDMO is managing quality processes and content for greater visibility and compliance across global manufacturing.

Contract Pharma Staff 12.16.20

Breaking News | Facilities | Industry News | QA/QC

The Wasdell Group Earns ISO 13485 Certification

The newly certified facility will provide a base for PPFL services in Ireland.

Contract Pharma Staff 12.14.20

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

UK’s VMIC to Implement Lonza’s MODA-EM

To digitize its Microbiology Quality Control operations.

Contract Pharma Staff 12.08.20

Capsules | Formulation Development | Methods Development | Process Development | Validation

Corealis Pharma

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Yves Roy, President 12.01.20

Biologics, Proteins, Vaccines | Inspections | Supply Chain

Inspecting the Unexpected

Preparing quality control processes for COVID-19 vaccine candidates.

Dr. Andrea Sardella and Raffaele Pace, Stevanato Group 11.17.20

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

Regis Custom Pharma

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Deanna Rentner, Marketing Coordinator 11.12.20

Validation

Particle Technology Labs

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Kelli Hubert, Customer Service Manager 10.29.20

Breaking News | Facilities | Industry News | QA/QC

Wuxi Griffin Completes Investment in New QC Lab and Storage Facility

Offers fully equipped microbiology and analytical testing lab for bulk and final product testing.

Contract Pharma Staff 10.26.20

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