FDA Consulting

FDA Consulting Areas

As FDA consultants, we provide, but are not limited to, FDA consulting services that fall under the following areas of FDA jurisdiction.

Medical Devices and IVDs

  • Device Design and Development including IVDs
  • Quality Management Systems
  • Quality System Regulations
  • Complaint Handling Systems
  • Design Control
  • Document Control
  • Medical Device Reporting
  • Risk Management
  • Patient Safety Signals
  • Device Labeling
  • 510(k) Clearances
  • PMA Approvals
  • Device Registration and Listing
  • CDRH Appeals
  • All Other Device Matters.

Drugs, Biologics, Compounding Pharmacy and Compliance Matters

  • FDA Inspection Preparation and Readiness
  • Combination Products
  • Biologics
  • Drugs
  • Interpretation of Laws, Acts, Regulations, and FDA Guidance
  • FDA Enforcement
  • Drug Registration and Listing
  • Imports and Exports Compliance
  • Surveillance
  • Postmarket Requirements and Commitments
  • Pharmacy Compounding

Other FDA Consulting Areas, But Are Not Limited to

  • Affordable Care Act (ACA 6004)
  • Bioequivalence Recommendations for Specific Products
  • Biologics Price Competition and Innovation Act of 2009
  • Drug Compliance Programs
  • Interpreting and Implementing FDA Guidances (All Areas Including Drugs and Medical Devices)
  • Newly Added Guidance Documents
  • Nicotine-Containing Products
  • Postmarketing Requirements – Postmarket studies and clinical trials
  • FDA Compliance
  • Prescription Drug Promotion
  • Regulatory Guidance Drug Registration and Listing
  • Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval
  • Responding to 483s, Untitled Letters, Warning Letters and Consent Decree (Permanent Injunction)

Food

    • Ingredients, Packaging & Labeling: Information about ingredients, additives, contact substances, GRAS, allergens, and nutrition labeling.
    • Dietary Supplements: Using dietary supplements and FDA’s role in regulating supplement products and dietary ingredients.

    Last Updated: 2016-10-24