FDA Consulting

FDA Consulting and Training Services

Our regulatory consulting services include, but not limited to, the following areas.

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

Training Services (Online or In-Person Seminars)

  • Training webinar, in person seminar or workshop for 510(k) drafting, PMA drafting, CE marking, QSR/GMS/cGMP compliance matters, global laws and regulations on drugs and medical devices.
    • we provide training webinars or seminars – invitation only.
  • Staff and management training on employment matters

Other FDA Consulting Areas

  • 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: 2020-06-05