KGK Synergize to launch GMP auditing firm

By Hank Schultz contact

- Last updated on GMT

Related tags: New product development

The goal of GMP Auditing Partners is to help companies with GMP compliance, including fixing problems found during inspections.
The goal of GMP Auditing Partners is to help companies with GMP compliance, including fixing problems found during inspections.
Contract research organization KGK Synergize Inc. is broadening the scope of its expertise with the formation of a new company called GMP Auditing Partners and has named industry veteran Ed Wyszumiala as CEO.

Wyszumiala has had experience on the auditing and certifying side of the coin during his recent tenure with NSF International where he was general manager of certification programs. Leading the new company will help him do what he could not with NSF, namely to help companies do what needs to be done to come into compliance, as opposed to enumerate what needs to be done.

“I have always been in a role where I could help companies diagnose problems, but now I am in a place where we can help companies fix the problems,”​ Wyszumiala told NutraIngredients-USA.

“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,”​ said Najla Guthrie, president and CEO.

Broad range of capabilities

The new company will have a broad range of capabilities.  KGK Synergize, as the parent company, can provide laboratory expertise, Wyszumiala said.  And with GMP Auditing Partners, which will formally launch at the Supply Side West trade show in mid October in Las Vegas, NV, he will seek to form a wide array of partnerships.

“One of the things I’ve seen in my years in the industry is there really isn’t a full service organization out there to help companies with all the issues that can crop up after an inspection, with cleaning up the problems noted in a 483, etc.  With three out of four companies, according to FDA, struggling with compliance  I certainly think there is a market for this,” ​Wyszumiala said.

“We are working to put together partnerships with a wide range, diverse group of professionals and experts,” ​he said.

Direct referrals

“I am working on a direct referral piece to help companies with how to handle recalls and how to handle adverse event reports,”​ he said. “Previously, I was in a position where you could diagnose people’s problems.  But you could see that companies were sometimes at a loss of where to go to fix those issues.  It is still somewhat word of mouth.

“It’s not like the pharmaceutical industry or the medical devices industry. One of my long term goals to form a coalition of consultants where we could all better offer these services to industry,”​ Wyszumiala said.

After Wyszumiala left NSF earlier this year he has been operating his own consulting service.  In addition, in April he was named president of the Natural Algae Astaxanthin Association, a position he plans to continue to fulfil for the foreseeable future.

KGK Synergize is a contract research and product development provider. It operates two divisions, a Contract Research Services (CRS) division and a New Product Development division. The New Product Development division implements screening techniques to develop nutraceutical and functional food products to the point where they are ready to market. The CRS division provides a wide range of research studies to third-party organizations.

Related topics: Regulation, GMPs, QA & QC

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