FDA Compliance Strategies

Developing and implementing successful GXP quality systems and compliance strategies are what we do best. Our consulting services integrate seamlessly with your operations and provide targeted, expert resources on demand.

Every client project benefits from our extensive knowledge of U.S. FDA and global regulations and guidelines in the following areas:

  • Analytical/Quality Control (QC) Support
  • Clinical and GCP Support
  • CMC and Regulatory Affairs Support
  • Compliance Audits and Gap Assessments
  • Corrective Action and Preventive Action (CAPA)
  • GXP Audits (Qualification, For Cause, Milestone)
  • FDA Strategies
  • Formulation Development
  • GCP, GLP, GMP, ISO and QSR Compliance
  • Manufacturing Compliance Oversight
  • Manufacturing Engineering and Support
  • Methods Development
  • Microbiology Support
  • Packaging Engineering and Validation
  • Part 11 Compliance
  • Project Management
  • Technical and Document/SOP Writing
  • Training Programs: Standardized or Customized
  • Validation: Cleaning, Equipment, Process, Software


GXP REGULATORY INSPECTIONS

  • FDA-483 and/or Warning Letter Response & Remediation
  • Inspection Support and Facilitation
  • Mock GXP Regulatory Inspections
  • Pre-Approval (PAI) Auditing, Preparedness, Training
  • Site Training and Preparedness
  • Sponsor/CRO/CMO Training and Preparedness