The Regulatory Compliance Experts! Helping Our Customers Succeed!!
The Regulatory Compliance Experts! Helping Our Customers Succeed!!
GK Regulatory Compliance & Engineering Consulting Corporation
GK Regulatory Compliance & Engineering Consulting Corporation

What We Do?

We provide the MOST AFFORDABLE services in;

Commissioning/De-Commissioning, Facilities Qualification, Validation, Quality System Implementation, Quality Audit, Quality System, Remediation, Regulatory Compliance, Regulatory Affairs, Engineering & Design.

We Also prove services and solutions to the life sciences industry in US, Latin America, Europe, and Asia.

 

Best-in-class technical expertise, operational knowledge and innovative solutions

 

 

Who We Are

GK is a Certified Woman -Owned Business Corporation, certified by MWBO, and Member of the US Chamber of Commerce Founded in 2011, owned and managed by industry-trained professionals.

Our Professional Staff are veterans of major pharmaceutical companies; therefore, we understand and know what you are facing.  All of our officers have at least fifteen to twenty plus years of hands-on experience compliance, regulatory and quality, including Regulatory Affairs, Auditing, Consent Decree, Warning Letters, Regulatory Compliance, Validation, computer hardware, networks, software, utilities and manufacturing / laboratory equipment, etc.

 

 

 

Where We're Headed!

GK is focused within the bio-pharmaceutical, Bio-similar, Drug Manufacturing, Pharmaceuticals, and Medical Devices, Cosmetic industry.

Were actively and routinely participating with on-site work. Giving our client a special one to one approach.  This assures both service and excellence.

 We strive to be current with regulations, iindustry standards, and trends. Creating deliverables, providing Regulatory Compliance services that stand up to FDA inspections.

 

 

 

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