KGK Synergize Inc., a contract research organization (CRO) offering human clinical trials to the health nutrition industry, has formed a new company, GMP Auditing Partners, which will be introduced at the SupplySide West Show in Las Vegas, Oct. 6 to 10, 2014. GMP Auditing Partners is a consulting firm that will help manufacturing and ingredient suppliers solve GMP compliance problems, provide regulatory guidance and develop best business practices.
“We are excited about the launch of GMP Auditing Partners,” said Najla Guthrie, president and CEO of KGK Synergize Inc. “Given the recent push from the FDA with regard to their GMP inspections, we felt this was the next logical step in the growth of services offered by KGK Synergize Inc.”
KGK Synergize Inc. has appointed Ed Wyszumiala as CEO of GMP Auditing Partners. Prior to this position, Mr. Wyszumiala was head of NSF International’s dietary supplement programs, where he ran and managed their GMP certification and product certification programs. Mr. Wyszumiala has worked closely with global regulatory agencies, as well as the industry executives at over 400 companies to ensure GMP manufacturing compliance and provide regulatory guidance and strategies.
“I am looking forward to growing GMP Auditing Partners,” said Ed Wyszumiala, CEO of GMP Auditing Partners. “Since 2010, the FDA has been stating that three out of four companies had demonstrated GMP deficiencies during their inspections. GMP compliance is a complex regulation to interpret; companies need a partner who understands these regulations and can help interpret them. At GMP Auditing Partners, our experts and knowledge is unmatched regarding GMP regulations. Our staff has former FDA officials, veteran industry auditors and analytical chemists, to deliver the confidence and expertise you would expect from Your Partner in GMP Compliance.”