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Regulatory Compliance

Blog: Agency-Accepted Testing and Filing Strategy for Elemental Impurities

The new elemental impurities regulations stress the importance of controlling all sources of ...

White Paper: Insight into Orphan Drug Formulations and Regulations

The US Orphan Drug Act of 1983 characterizes an orphan disease as a rare medical condition that...

Beyond the Label: Four Challenges to Serialization

Many pharmaceutical manufacturers are concerned about label design and placement to accommodate a...

Important Steps for Quota, Import, and Export Processes for DEA Controlled Substances

Controlled drug substances are scheduled based on medical use in treatment, potential for abuse,...

Case Study: Implementing Serialization

The Food and Drug Administration (FDA) issued a draft guidance listing the enforcement of product...

Listicle: Serialization CDMO Checklist

Given that serialization execution is new to many in the industry, what should drug developers look...

Serialization - Data Management Challenges

The implementation of the Drug Supply Chain Security Act (DSCSA) requirements poses many...

Serialization Overview: What’s Required for November 27, 2017 Deadline

New requirements under the Drug Supply Chain Security Act (DSCSA) have been set for manufacturers,...

Elemental Impurities USP: The Risk-Based Approach

The U.S. Pharmacopeia (USP) intends to remove the existing wet chemistry heavy metals methods...

Elemental Impurities: Updated Regulatory Requirements

In 2013, the International Conference on Harmonization (ICH) approved ICH Q3D, a Guideline for...