Our Services



The FDA Group Consultant’s Core Competencies Include:

Compliance Consulting Services:

  • Compliance Master Planning and Strategy
  • Preparation for Inspections
  • Mock Pre-Approval Inspections (PAI) and Mock FDA Audits
  • Vendor / Supplier Audits
  • GxP Audits (GMP, GCP, & GLP)
  • Clinical Site Audits
  • Gap Analysis
  • Formal Risk Assessments & Risk Mitigation Strategies
  • Support with 483′s / Warning Letters / Consent Decrees
  • Quality Systems & Corporate SOP Guidance and Development
  • Label, Package, Insert, Brochure, & Website Review
  • Expert Witness Testimony
  • Training & Development of Training Programs
  • International Quality Experience (Europe, Canada, Brazil, & Mexico)

Creation and/or Review of Regulatory Filings:

  • Investigational New Drug (IND) Applications
  • Investigational Device Exemptions (IDE)
  • Premarket Approvals (PMA)
  • New Drug Applications (NDA)
  • Abbreviated New Drug Applications (ANDA)
  • Biologics License Applications (BLA)
  • 505(b)(2)’s
  • 510(k)’s
  • De Novo Applications
  • Assistance with Importation, Import Alerts, & Detention
  • International Regulatory Experience (Europe, Canada, Brazil & Mexico)

Interim Placement & Permanent Recruitment:

  • C-level, VPs, Directors, and Managers
  • Quality Assurance
  • Regulatory Affairs
  • Clinical Operations

Validation & Qualification Services:

  • Facility Layout, Utility Design, & Process Review and Assessment
  • Validation Master Plans
  • Equipment & Instrumentation Qualification
  • Utilities Qualification
  • Process Validation
  • Cleaning Validation
  • Analytical Methods Validation
  • IT Qualification and Computer Validation
  • 21 CFR Part 11 Compliance Strategies
  • Training & Development of Training Programs