Listing Page

Tag: regulatory

Navigating Regulatory Landscapes: Simplifying Compliance to Streamline the Drug Approval Process
The global regulatory landscapes for pharmaceutical and biopharmaceutical products are as complex as...
Read More >
Navigating API Sourcing as a Pharmaceutical Manufacturer
What will your sourcing team do when a challenge occurs with an active pharmaceutical ingredient (API)? The...
Read More >
Why CDMO Project Management is Critical for Small Pharma Companies
For small pharmaceutical companies with niche products at a contract development and manufacturing organization...
Read More >
Final Deadline: Completing DSCSA Track & Trace Implementation Before November 2023
As we discussed last September, counterfeit drugs are not only big business, but they also pose a significant...
Read More >
Best Practices for Successful Method Validation
When method validation is performed incorrectly, companies pay a price in multiple ways. Inaccurate method...
Read More >
What You Need to Know About Post-Approval Change Pathways
Post-approval changes (PACs) – changes made to the drug substance manufacturing process after receiving...
Read More >