Resources

Medical Devices When a medical product fails in the field, everyone suffers — not just the patient, but also the manufacturer and its employees, investors, suppliers, and even competitors. No...

Whether you need support with Product Development, Formulation Development, Compliance Assurance, Clinical and Manufacturing Development, Guidance and Pathways for Biologic/Biosimilar Approval, FDA Briefing, or Application Submission, RCA. can help. Download...

For medical device manufacturers, technology can be a double-edged sword. The technologies that elevate the quality of life for patients can be used by cybersecurity bad actors to potentially harm...

Introduction The intent of this cGMP article is to stimulate more conversation and catalyze more improvement across our industry relating to the repeat problems we have seen for literally decades....

Q: My company is preparing to transfer in a new product to one of our manufacturing facilities. Previous technology transfer pharmaceutical projects have not always gone smoothly for us. How...

Q. I work for a contract manufacturer, and I think we have robust CAPA systems. Sometimes we close our CAPAs before we have completed our effectiveness check due to the...