FDA Consulting Services
We have an experienced team of ex-FDA and industry consultants who are highly skilled in all aspects of FDA compliance, quality systems, and GMP issues (Good Manufacturing Practice Regulations).
Our consultants will work closely with your management team to ensure that everything is done right the first time – from the initial gap analysis to implementation and continuous improvement of quality control systems.
Our FDA consulting services include:
- 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
- SOP development (Standard Operating Procedure)
- website and labeling review
- CAPA (corrective and preventive actions)
- FDA complaints
- FDA recalls
- MDR (medical device reporting)
- S/AER (Serious / Adverse Event reporting)
- 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 offer consulting on FDA regulatory issues to all types of industries regulated by the FDA, including: medical device, dietary supplement, tobacco, drug / pharmaceutical, biotech, and food producers.