• Global Leader

    in Compliance Consulting,

    Regulatory Services

    & Executive Recruitment

The FDA Group is a global leader in FDA compliance consulting, regulatory services, and executive recruitment for the pharmaceutical, biotechnology, medical device / diagnostics, and food industries.

Headquartered in Westborough, Massachusetts, The FDA Group also has satellite offices and staffed presence across the nation and around the globe.

Contact The FDA Group Today & Achieve Your Goals

 The FDA Group’s services include:

Compliance Consulting Services:

  • Compliance Master Planning and Strategy
  • Mock Pre-Approval Inspections (PAI) and Mock FDA Audits
  • Vendor / Supplier Audits
  • GxP Audits (GMP, GCP, & GLP)
  • 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 & Executive 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

 

Why choose us? We command:

  • Client satisfaction: Dedicated to understanding and responding to our clients’ needs, providing insight into current industry and regulatory trends and initiatives so as to meet or exceed all client expectations.
  • Continuous improvement: Committed to a culture of Total Quality to optimize our service quality, client satisfaction, and client profitability.
  • Public responsibility: Committed to honesty, integrity, accountability, and responsibility in all aspects of our work.

Click Here to Contact The FDA Group Now