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
