FDA Consulting Consultation

FDA Compliance Group is pleased to offer consultations to all types of FDA regulated businesses and organizations.

During your consultation, we can discuss your specific needs, how we can best serve you and our rate structure for services.

Our Primary FDA Compliance Consulting Services

• Mock FDA audits and inspections
• Due Diligence audits for mergers and acquisitions
• FDA Form 483 responses
• FDA Warning Letter responses
• FDA labeling and website reviews
• Audits and gap analysis
• SOP development
• Specification development
• Master manufacturing records and batch record development
• FSVP compliance
• MoCRA compliance
• S/AER (Serious Adverse Event Reporting) and MDR (Medical Device Reporting)
• FDA submissions and applications

We provide support to companies of all sizes, from startups to multinational corporations, in medical devices, dietary supplements, pharmaceuticals/OTC, cosmetics, clinical trials, food & beverage, and tobacco.

We also provide technical support for law firms who work with clients on FDA regulations and compliance.

Ready to discuss your FDA compliance needs? Contact us to schedule your consultation.