Avomeen’s industry-leading Ph.D. scientists provide extensive regulatory and analytical support to numerous med device companies. We combine unrivaled regulatory and scientific expertise, advanced equipment, and an unmatched client-centric experience to ensure timely compliance to regulatory standards.
Our expert scientists provide comprehensive and thorough analytical testing and regulatory support for conventional and novel medical devices, drug-device combination products, and post-market approvals.
- Chemical Characterization
- 510(k) Deformulation
- Stability Programs
- Extractables & Leachables Testing
- Method Development & Validation
- Formulation & Process Development
- Quality Control
- Cleaning & Process Validation
- Contamination ID & Failure Analysis
- Regulatory & Compliance Support
- Intellectual Property & Litigation Support
Why Partner with Avomeen?
Discerning med device companies trust Avomeen’s Ph.D. scientists and decades of industry experience to provide dependable delivery and unrivaled customer service. Here are some of the benefits of partnering with us:
- cGMP compliant, FDA registered, and DEA licensed
- Consultative, nimble, and responsive staff
- Project customization to your specific needs
- Experience in solving difficult analytical and formulation challenges
- Delivery within tight timelines
- Up-to-date regulatory knowledge to ensure compliance