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A Full Service Active Pharmaceutical Ingredient Supplier

Raising the Level of cGMP Compliance in China

A Key to chemwerth's success is our full range of regulatory services,
employed to support both our customers and manufacturers.

chemwerth is constantly working behind the scenes making certain that our manufacturers stay ahead of the cGMP curve. In addition to our routine audits and National Training Center in Shanghai, chemwerth holds annual educational seminars for all of our represented API manufacturers.

image3chemwerth's Regulatory Seminars typically educate more than 100 attendees on the most current and important issues in the pharmaceutical industry. Our entire regulatory staff is on hand to introduce the latest in cGMP compliance. We are expanding our seminar to include both Regulatory and New Product information. Attendees will be able to expand their knowledge of post approval regulatory compliance and development of new products for the US market.

In addition to covering the most current cGMP regulations and guidelines, our staff provides specific step-by-step procedures for such topics as:

  • Good Laboratory Practices (GLP)
  • Impurities and Related Substances
  • Instrument Calibrations, IQ, OQ, PQ
  • Methods Validation
  • Organic Volatile Impurities, Residual Organic Solvents Guidelines
  • Process Water
  • Stability Studies

chemwerth's step-by-step procedures leave nothing to chance. cGMP compliance is a certainty with API manufacturers represented by chemwerth.

 

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