Consultation ~ FDA Consulting Services

We're pleased to offer a consultation to all types of businesses and organizations that are regulated by the FDA.

In this consultation, we can discuss what you need, how we might best serve you, and the rate structure for our services.

Our primary consulting services for FDA compliance include:

• FDA Form 483 responses
• FDA Warning Letter responses
• FDA labeling and website reviews
• Audits and gap analysis
• mock FDA inspections
• S/AER (Serious Adverse Event Reporting) and MDR (Medical Device Reporting)
• FDA submissions

We provide support for all sizes of companies, from start-ups to multi-national corporations, across the range of FDA regulated industries, including: medical devices, dietary supplements, drugs, clinical trials, and food & tobacco.

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

To schedule a consultation for FDA consulting services, please contact us.