by Faith Fraley, Director, CQV Engineering at Kymanox Every pharmaceutical manufacturing facility requires a controlled manufacturing environment. Temperature, humidity, and pressure are crucial to products …
Building Tomorrow’s FDA/EMA Compliant Intelligent Enterprise Solution
by Brian Freymann, Director, Enterprise Solutions The core issue that drives compliant solutions is that drug, medical device, and instrumentation companies are monitored closely by …
Kymanox Exhibits at the 2017 PDA/FDA Joint Regulatory Conference
For more than 25 years, the U.S. FDA and PDA have collaborated on the PDA/FDA Joint Regulatory conference. Participants have the opportunity to engage directly with …
SAP / ERP – FDA Compliance
QUALITY BY DESIGN (QBD) & PATIENT CENTRICITY Our overall approach to providing solutions is based upon the principles of Quality by Design (QbD) and patient centricity. In addition …
Medical Device Design Controls
Developing a new medical device from concept to market can be a complex process. Design controls are an interrelated set of practices and procedures that …
Good Manufacturing Practices (GMP)
The Federal Food, Drug, and Cosmetic Act (FDCA), signed into law in 1938, gives the FDA the authority to regulate the sale of food, drugs, …
Cleaning Validation
In 1988, Cholestyramine Resin USP finished drug product (a cholesterol medication) was recalled due to cross-contamination with low levels of an agricultural pesticide. The contamination …
Good Clinical Practice Compliance Solutions
Practical Hands-On Experience Kymanox has a diverse body of work, practice, and professional experience – exclusively focused on the life sciences. We understand your business …