FDA CONNECTION GROUP INC

Website: Company Website

Address: 7830 E Camelback Rd Unit 410, Scottsdale, Arizona, 85251-2236

Phone: (571) 246-3142

Contact Person: NATE WILLIAMS

Legal Structure: Subchapter S Corporation

Year Established: 2020

Business Type: Service (100 %)

Principals: 1. Geoffrey Nate Williams, President/CEO

Ownership: Black American, Other Minority Owned

Products & Services

FDA Connection Group, Inc. is a 3rd party FDA consulting group specializing in analytical, clinical, regulatory, and compliance affairs specific to FDA approvals for our Clients. Our Team is proficient in writing Investigational New Drug Applications, Clinical Trial Strategy, Auditing, and Monitoring plans as well as certified in Good Clinical Practices, Good Manufacturing Practices, and Good Laboratory Practices. Most importantly, we fully understand and capable of translating to our clients FDA Quality System Regulations and Compliance, International Conference on Harmonization, and International Organization for Standardization (IND,GCP/GMP/GLP/QSR/ICH/ISO) requirements for the Pharmaceutical, Medical Device, and Biologic industries.

Keywords

  • Good Manufacturing Practices
  • Good Clinical Practices
  • Ind
  • Investigational New Drug
  • Capa
  • Ndas
  • Andas
  • Pre-market Approvals
  • Plas
  • Blas
  • 510ks
  • Gmp
  • Gcp
  • Ra/qa
  • Regulatory Affairs
  • Quality Assurance
  • Qa/ra
  • Pma
  • Glp
  • Good Laboratory Practices

NAICS Code(s)

  • 325413: In-Vitro Diagnostic Substance Manufacturing
  • 325414: Biological Product (except Diagnostic) Manufacturing
  • 541380: Testing Laboratories
  • 541611: Administrative Management and General Management Consulting Services
  • 541618: Other Management Consulting Services
  • 541690: Other Scientific and Technical Consulting Services
  • 541720: Research and Development in the Social Sciences and Humanities
  • 541990: All Other Professional, Scientific, and Technical Services
  • 561990: All Other Support Services

Contract History

Name: Arizona State University

Contract: clinical trials

Start: 06/06/2020

End:

Value:

Contact: Jim Adams

Phone: 480-818-0741

Name: R3 Stem Cell

Contract: IND Documentation

Start: 10/15/2020

End:

Value:

Contact: Dr. David Greene

Phone: 602-677-8981

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