News & Events

2 min read

A2LA, ANAB OR  NVLAP? DECODING THE DIFFERENCES IN ACCREDITING BODIES

1 min read

Powering Through Adversity: Backup Generators Ensure Pharmaceutical Safety During Emergencies

1 min read

Testing Ethylene Glycol and Diethylene Glycol in High-Risk Drug Components

2 min read

EMPQ Case Study: Carolina Components Group

1 min read

QbD Addresses API Supply in Orphan Drug Formulation

5 min read

EDITORIAL: Combination Products and their Regulatory Pathway

4 min read

Blog: 505(b)(2): What You Need to Know

5 min read

Blog: Successful Methods for Obtaining Orphan Drug Approval

4 min read

White Paper: The Changing R&D Landscape

Editorial: Considerations for Approval of Biosimilars

eBook: Analytical Testing in Drug Development

2 min read

Blog: Introduction to Quality by Design

3 min read

Case Study: Abeona Therapeutics

4 min read

Blog: Regulatory Requirements for Early Phase Drug Product Development

2 min read

Designing a CMC Strategy for Accelerated Biologics Development

1 min read

St. Louis Facility Issued European Medicines Agency Certification

1 min read

Agency-Accepted Testing and Filing Strategy for Elemental Impurities

8 min read

White Paper: Insight into Orphan Drug Formulations and Regulations

3 min read

Beyond the Label: Four Challenges to Serialization

3 min read

Quota, Import, and Export Processes for DEA Controlled Substances

ON-DEMAND WEBINAR: Elemental Impurities

2 min read

Case Study: Implementing Serialization

1 min read

Listicle: Serialization CDMO Checklist

1 min read

QUALITY SPOTLIGHT: Elizabeth Oxendine

2 min read

Serialization - Data Management Challenges

2 min read

Elemental Impurities USP: The Risk-Based Approach

1 min read

Elemental Impurities: Updated Regulatory Requirements