Compliance

Breaking News | Facilities | Industry News | Inspections

Symbiosis Completes Successful MHRA Audit

Will expand facility at its Stirling, UK site with new storage and warehousing capability.

09.16.21

cGMP Manufacture | Drug Development | QA/QC

Three Tips for Navigating Post-Approval Pharmacovigilance

Seamlessly transition from regulatory reporting to post-approval safety surveillance in today’s market.

Emmanuel Belabe, Associate Vice President, Safety Product Management, ArisGlobal, Nina Patel Lahanis, Associate Vice President, Safety Science, EVERSANA 09.08.21

Breaking News | Facilities | Industry News | Regulatory Affairs

Sterling Pharma Solutions Recognized for Achievements in Sustainability

Awarded Gold Medal by EcoVadis.

09.03.21

FDA Approves Pfizer-BioNTech COVID-19 Vaccine COMIRNATY

Grants first full approval for COVID vaccine.

08.23.21

CMO Becoming a Powerhouse With Expansions and New Facilities, Looking to Add Strategic Customers

Aphena is a service provider in the pharmaceutical, OTC, medical device, biologics and personal care industries.

Sponsored released by Aphena Pharma Solutions 08.10.21

Drug Development | Scale-up/Technology Transfer | Validation

Keys to Successful Tech Transfer for Topical Pharmaceuticals

This whitepaper illustrates the keys to choosing the right manufacturing partner and how to manage a topical drug tech transfer.

APIs | QA/QC | Validation

Microbiological Testing Considerations for Pharmaceutical Products

Microbiological testing is a critical component to ensuring the quality and safety of pharmaceutical products. Explore more in this webinar on August 26.

07.26.21

Bioanalytical Services | Biologics, Proteins, Vaccines | Filtration & Purification | QA/QC | Reader Showcase

MOBILion Launches MOBIE HRIM for Biotherapeutic Drug Development

Designed to address characterization challenges during biopharmaceutical drug development and quality monitoring.

07.21.21

Breaking News | Industry News | QA/QC | Regulatory Affairs | Supply Chain

United States Pharmacopeia Acquires Pharmatech Associates

Expanded offerings will help regulated life science companies strengthen the supply chain for safe, quality medicines.

07.09.21

APIs | Breaking News | GMPs/GCPs | Industry News | QA/QC

Purisys Obtains Two Global ISO Certifications

Now certified for ISO 17025 for Testing and Calibration Laboratories and ISO 17034 for Reference Material Producers.

07.08.21

Breaking News | Facilities | Industry News | Validation

Almac’s Charnwood Site Receives ISO Certifications

Achieves globally recognized Health & Safety and Environmental Management System certifications.

07.06.21

Establishing Commercial Manufacturing Services for Antibody-Drug Conjugates

Learn how to properly structure your development work, perform a thorough process risk assessment and prepare for pre-approval inspection audit.

Sponsored released by MilliporeSigma 06.09.21

Inspections | Validation

From Capital Builds to Staff Augmentation: Tips to Achieving Integrated CQV Strategies

An integrated CQV strategy can support current projects and ongoing operations. This webinar will cover integration strategies in several key areas.

06.09.21

Information Technology | QA/QC | Regulatory Affairs

The Importance of Data Integrity Risk Assessment

Executing Data Integrity Risk Assessments for systems that generate and store both paper (manual)-based systems as well as computer-based and hybrid systems.

Paul Mason, Ph.D., Lachman Consultants 06.07.21

Breaking News | Facilities | Industry News | Inspections

CPL Completes Successful Virtual Health Canada Audit

The CDMO created a virtual tour of its facilities in response to the pandemic.

Tim Wright, Editor, Contract Pharma 06.03.21

Regulatory Affairs

Meeting with the FDA: Valuing the Statistician and Preparation for Review

A look at the key roles and responsibilities of FDA and biopharmaceutical industry statisticians throughout product lifespan.

Joshua Baker, VP and LaRee Tracy, PHASTAR 05.27.21

ADMA Receives FDA Approval for Increased IVIG Production Scale

Increases plant manufacturing capacity from 400,000L to 600,000L.

Tim Wright, Editor, Contract Pharma 04.29.21

Breaking News | Facilities | Industry News | Inspections

Bora Pharmaceuticals Completes Health Canada Inspection

Mississauga site is the company’s first manufacturing facility in North America and is its HQ in the region.

Tim Wright, Editor, Contract Pharma 04.23.21

Clinical Trials | R&D | Regulatory Affairs

Unifying Quality Manufacturing to Drive Speed, Collaboration, and Compliance

Learn how you can unify end-to-end quality management to improve visibility, efficiency, and compliance in this webinar on May 13.

04.22.21

Jubilant HollisterStier CMO

Jubilant HollisterStier Contract Manufacturing & Services is an integrated contract manufacturer of sterile injectables, ophthalmics, otics and sterile and non-sterile topicals and liquids.

Marcy Edwards, Marketing Manager 04.16.21