An Experienced FDA Consulting Firm
FDA Compliance Group has an experienced team of ex FDA and industry consultants who are highly skilled in all aspects of FDA compliance, quality systems, and Good Manufacturing Practice Regulations (GMP).
Our FDA consulting firm will work closely with your management team to ensure that everything is done right the first time, from the initial gap analysis through implementation and continuous improvement of your quality control systems.
Our FDA consulting services:
- Form 483 responses and Warning Letter responses
- FDA applications / submissions
- FDA compliance master plans
- Compliance strategy planning
- Project management, including metrics and oversight
- Gap analysis
- Mock FDA audits and inspections
- Standard Operating Procedure (SOP) and specification development
- Website and labeling review
- Corrective And Preventive Actions (CAPA)
- FDA complaints and recalls
- Medical Device Reporting (MDR)
- Serious / Adverse Event Reporting (S/AER)
- Training programs
- Management controls
- Document controls
- Change controls
- Design controls
- Production / process controls
- HACCP
- Technical support for law firms that specialize in FDA regulations
- Training on FDA requirements (laws and regulations)
For more information on FDA consulting services or to schedule a consultation, please contact us.
We consult across all FDA regulated industries, including medical devices, dietary supplements, tobacco, drugs and pharmaceuticals, biotech, and food producers.