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.
GK Focused within the biopharmaceutical, Biosimilar, Drug Manufacturing, Pharmaceuticals, and Medical Devices, Cosmetic industry.
Our services include, but not limited to;
Commissioning/De-Commissioning, Facilities Qualification, Validation, Quality System Implementation, Quality Audit, Quality System, Remediation, Regulatory Compliance, Regulatory Affairs, Engineering & Design,providingservices and solutions to the life sciences industry in US, Latin America, Europe, and Asia.
We provide the MOST AFFORDABLE services you will ever find.
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.
We (up to and including the GK Regulatory, Compliance & Engineering Consulting Corporation president, actively and routinely participate with on-site work. Giving to our client a special one to one approach. This assures both service and excellence.
By being current with regulations, industry standards, and trends, creating deliverables and providing Regulatory Compliance services that stand up to FDA inspections.