Summary

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

Description

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.

Profile

  • Incorporated in
    Arizona
  • Established since
    2020
  • Main/Branch
    Branch

Address

Contact