Innovative Toxicology, Inc. has initiated and managed medical device FDA
approvals, global component registrations, safety clearances, and cGMP
audits. Services for medical device manufacturers and component suppliers
include:
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- Establishing client needs
- FDA interfacing for program design
- Coordinating the implementation of program design
- Experimental design for preclinical animal testing
- Coordination with contract testing laboratories
- Clinical safety study implementation
- Data interpretation and risk assessment
- FDA document preparation
- Providing support during FDA petition review
- Auditing for cGMP compliance