Insights On Regulatory Compliance
-
Successful Filter Integrity Testing Using The WIT Method
11/15/2022
Explore the collected best methods/practices to give filter end users the best possible chance of performing a successful water intrusion test.
-
Developing Injectable Drug Placebo Formulations For Clinical Trials
1/9/2024
Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.
-
Combat Major Cell And Gene Therapy Manufacturing Regulatory Obstacles
8/8/2023
As cell and gene therapies grow in the pharmaceutical industry, drug sponsors must determine how to successfully navigate evolving regulations, study design considerations, and a lack of animal models.
-
A Guide To Pharmaceutical Quality Management
6/16/2022
Despite the inherent challenges of connecting quality and compliance data, there are tools that can help you to ensure quality's connectedness and central bearing.
-
High-Velocity Development: Gene Therapy Vs. Small Molecule
12/26/2023
Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.
-
Compliance: Framing Success Utilizing PIC/S And EU GMP
12/20/2023
Explore the differences between the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guide and the EU GMP Guides, and gain insight into the teamwork between the FDA, MHRA, and PIC/S.
-
Integrated Annex 1 Compliance
6/5/2023
Learn about the critical changes in the Annex 1 guidance from a process equipment provider's perspective, several areas where process and product change could take place, and more.
-
Intro To USP <1062> - What It Is And Why You Should Use It
7/20/2023
Knowing how to use USP <1062> helps manufacturers manage the wide variety of factors that can exacerbate production costs, or result in no product at all.
-
Match Your Development And Manufacturing Path To Your IND Milestones
2/17/2023
The drug development journey is long, expensive, resource straining, and risky. Discover how to maximize the value of early phase material and match your development path to your IND milestones.
-
3 Ways To Improve QMS Documentation: Following International Standards
9/8/2022
We share how to get the most out of documenting your quality management system that can also help you stick to ISO 9001 standards.