Biotech Research Group understands the urgency of developing emergency use products during pandemics and natural disasters. Our Emergency Use Authorization consulting group has experience that expands beyond Emergency Use Authorization of Medical Products and Related Authorities, product development, and quality compliance.
Our EUA Consultants can provide the following services:
- Hand Sanitizer Development
- PPE Development
- Public Health Consulting
- Total Quality Management
- Hospital Infection Control Audit and Consulting
- FDA Establishment Registration
- Product Listing
- COVID-19 Consulting
- Infectious Disease Consulting
- PPE Consulting (gloves, masks, gowns, face shields)
- Hand Sanitizer Consulting
- Test kits
Per the Federal Food, Drug, and Cosmetic Act (FD&C Act), the US Food and Drug Administration allows for the emergency use of some medical products under certain circumstances. An Emergency Use Authorization (EUA) provides FDA with the authority to support emergency preparedness and response, including supporting the development and availability of unapproved or new medical products (drugs, biological products and medical devices) for use in emergency situations.
Biotech Research Group supports EUA strategy and applications with a solid understanding of FDA requirements for COVID-19 related EUAs; we continue to keep abreast of changing requirements as they evolve throughout this time of emergency due to the current, global coronavirus pandemic. From providing strategic pathways for navigating various EUAs for COVID-19 products to developing commercial use plans for products available under EUAs, BRG can advise clients how to achieve their specific short-term and long-term goals to ensure they align with FDA requirements and guidance.
Our Emergency Use Authorization (EUA) Services
- Interpretation of FDA requirements and guidance related to new and evolving EUAs including regulatory pathway options
- Regulatory pathways for premarket requirements for continued commercialization after the EUA concludes, such as premarket notification
- Pre-EUA submission
- Support EUAs for IVDs, anti-body tests, PPE (masks, gown, etc.) and other medical devices
- Research and recommend new pathways as FDA revises guidance and EUA scope