FDA Compliance and Legal Services

Obtaining FDA approval and maintaining FDA compliance is a complex, ongoing process. Our FDA consultants are former FDA employees and industry experts, with extensive regulatory experience. We understand the FDA agency and how to navigate its infrastructure. We work with a wide range of law firms and assist with all FDA matters across all FDA regulated industries.

We can assist you with all of your FDA compliance, remediation, and legal issues in the areas below.

FDA Strategy, Audits, and Remediation

We help develop practical FDA compliance strategies that match your risk, resources, and timelines. Our services include:

• FDA audit and gap analysis (including mock audits)
• Remediation and corrective actions required by the FDA
• FDA compliance strategy planning
• Executive management strategy planning
• FDA inspection assistance
• FDA 483 response and remediation
• FDA Warning Letter review and responses
• Consent decree resolution
• FDA expert testimony

FDA Technical Assistance

We provide technical FDA support across your quality and regulatory systems including:

• Due Diligence audits - mergers and acquisition
• Complaints / CAPA
• MDRs (Medical Device Reporting)
• S/AER (Serious / Adverse Event Reporting)
• Reportable Food Registry
• FDA recalls
• SOP (Standard Operating Procedure)
• GMP (Good Manufacturing Practice)
• HACCP (Hazard Analysis and Critical Control Points)
• Management structure
• Design controls

FDA Food and Industry Support

For food and beverage companies, we support compliance with the Food Safety Modernization Act and related FDA requirements, assisting in:

• FSVP
• Food Safety Modernization Act
• Reportable Food Registry
• samphell eggs
• Drinking water
• Medical foods
• Low acid / acidified foods

FDA Compliance Training

We offer FDA compliance training tailored to your products and teams. Training can include:

• Technical training (including medical device, drug, dietary supplements, GMP, HACCP, lab, sterility, and specification development)
• FDA inspection
• FDA law

FDA Import Support

We assist with FDA import compliance, helping you prevent and respond to import issues. This includes support for:

• FDA detentions
• DWPE (Detention Without Physical Examination / automatic detention)

FDA Technical Support to Law Firms

We provide technical FDA support to law firms that represent FDA regulated companies. This can include:

• GMP and audit support
• Remediation support
• FDA submission
• FDA application
• FDA compliance

Our FDA compliance and consulting extends to all industries regulated by the FDA, including: medical device manufacturers, dietary supplement companies, pharmaceutical / drug companies, OTC, biotechnology companies, food producers, and tobacco companies.

For more information on FDA compliance and legal consulting services or to schedule a consultation, please contact us.