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

Services

We Ensurace Your Company Comply With;

Our program is consistent with industry standards and practices, cGMPs, and any other appropriate FDA guidelines, ISO Standards, CE Mark requirements and/or other policies.

Our consultants can help you develop a strategy to manage your regulatory compliance requirements so that you maximize the risk management aspects at the same time you minimize the impact of regulatory compliance on your resources.

 

Discover how Gk Regulatory, Compliance, & Engineering Consulting can help your company to achive its compliance and Business Goals.

GK Regulatory, Compliance, & Engineering Consulting Corporation, provides a team of engineers and regulatory compliance experts to work closely with our clients to develop comprehensive validation programs for their facilities to ensure they meet all applicable regulations. We have experience with compliance for all aspects. Our Team of experts ensure Compliance by Offering the Following Services:

 

Our Services Include:

  • Engineering Services
  • Project Management
  • FDA Compliance | Master Planning and Strategy
  • Preparation for Inspections
  • Pre-approval and Mock FDA Inspections 
  • Vendor / Supplier Audits
  • Validation Services
  • Corporate SOP Guidance and Development
  • Quality Systems Benchmarking/GAP Analysis
  • Quality Systems Auditing (cGMP/GLP/GCP/ISO)
  • Quality Systems Development, Implementation and Management Training
  • Regulatory Compliance Solutions (Support with Consent Decree, 483's, Warning Letters, etc.)
  • Development/Review/Assessment of FDA Submissions - Regulatory Fillings (INDA, NDA, ANDA, 510(k)s, PMA, etc.)
  • FDA Product Registration
  • Submission Strategies
  • FDA Inspection Coordination/Follow-up
  •  Training
  • CAPA Management
  • GMP
  • QSR
  • GLP
  • Part 11 - CSV

 

 

GK Regulatory, Compliance & Engineering Consulting Corporation.

 

 

1301 Riverplace Blvd.

Suite 800

Jacksonville, FL 32207

 

Office: 1+ 904-432-1211

Fax: 1+ 561-584-5842

Alternative #: 1 +609-902-4666

Please contact us anytime, we look forward to hear from you!

Office; 904-432-1211

or 904-608-7224

Email us Info@gkregulatorycompliance.com

www.gkregulatorycomplaince.com

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