Former FDA Investigator Joins ChemWerth, Inc. to Strengthen the cGMP Factory Compliance Program in China and India.

Woodbridge, CT. After 14 years with the Federal Drug Administration (FDA), FDA investigator Jeffery Hangartner joins ChemWerth, Inc. to strengthen the cGMP factory compliance program. Mr. Hangartner will be responsible for the Regulatory team in Shanghai and to ensure the cGMP compliance of all 27 Chinese factories represented by ChemWerth. Dr. Yaping Shen, General Manager of ChemWerth Shanghai, will assist Mr. Hangartner in working with the factory directors and presidents.  Mr. Hangartner will coordinate and schedule customer driven six-system audits, FDA inspections, and install cGMP improvement programs with each factory.

“ChemWerth is placing greater emphasis on factory total compliance because we believe that all regulating bodies around the world will continue to raise the compliance standards of Chinese and Indian API manufacturers.  Mr. Hangartner will be instrumental in providing a factory six-system audit program. This will allow dosage drug companies to meet ICH guidelines by auditing their API suppliers every two years at a large cost reduction”, stated Dr. Shen.

ChemWerth recently expanded its regulatory and new product development staff to 24 people in order to best meet the anticipated increased regulatory and compliance burden that factories will face in 2009. ChemWerth’s director of Regulatory Affairs, Dr. Tang Peng will coordinate with the customers in supporting this fee- for-service program.

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