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Q. I am a small-scale parenteral manufacturer and have been approached to support a clinical program through Phases II and III. What sterile manufacturing considerations are important for the small-scale...

Q: I am in the quality assurance department at my company. We are a small start-up, and one of my jobs is to develop a quality risk management plan. Can...

MDSAP is a standardized global auditing program which allows for a single regulatory audit of a medical device manufacturer’s quality management system (QMS) to be conducted to satisfy the requirements...

Client Challenge A global pharmaceutical and medical device company faced challenges in scaling its workforce to meet the demands of rapid business growth and increasing regulatory oversight. Specifically, the company...

Q: I am a quality control (QC) manager of a contract test laboratory. I am going to be upgrading the lab testing environment and would like to know if you...

Q: I work for a contract manufacturing organization (CMO) and our pharmaceutical manufacturing team has dedicated capital funds to update some of our manufacturing lines. I need to work with...