Regulatory/Compliance
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A Guide to EU FMD for CMOs: Compliance, Collaboration and Business Opportunity
Download our guide for CMOs to learn how to adapt your operations to meet your customers’ EU FMD requirements.
Case Study: Value Drug Company | DSCSA Product Investigation—A Compliance Solution
See how Value Drug Company standardized the process for illegitimate and suspect product investigations for DSCSA compliance.
India Regulatory Updates
View a compilation of the most recent track and trace regulations for the healthcare supply chain in India. Get insights into compliance updates.
Can You Afford a Manual Approach to EU FMD Compliance?
Manual data upload through the EMVO portal is simple in concept, but preparing and maintaining that data can be a challenge for smaller companies.
Automated Validation Manager: How It Works, and What's Included
Automated Validation Manager eases the burden of validation by testing functionality and providing a complete set of documents. Watch the video.
Navigating DSCSA: Choosing a Compliance Approach for Dispensers
Review the different approaches healthcare organizations can take to achieve DSCSA compliance.
Altran Q&A: Spain’s Small Pharmas Face Big Serialization Challenges for EU FMD
Understand the challenges small pharmas face as serialization approaches, and how industry expert Altran helps solve them.
Worldwide Regulatory Updates
Get insights into the most recent worldwide track and trace regulatory compliance updates for the healthcare supply chain.
What Are the 3 Major Requirements of EU FMD?
The EU Falsified Medicines Directive contains requirements for safety features and verification that details how companies must establish…
Preparing for DSCSA Saleable Returns Verification
Understand the impact of the upcoming DSCSA saleable returns verification requirement for both pharma companies and wholesale distributors.
Case Study: IBSA | Using Serialization to Ensure Product Integrity
Learn how IBSA used serialization to protect their product from counterfeiting.
Solving the Challenge of Trade Partner Requirements
Find out what happened when a wholesaler turned to TraceLink after getting an unexpected request.