With the advancements of technologies, MCRA is seeing more and more advanced biologics and combination products. In order to provide the necessary expertise on the data needed to demonstrate a device is safe to initiate a clinical study or enter the US market, MCRA has developed an expert team of engineers and scientists that provide the following services:
- Early-stage preclinical strategy and planning for medical devices and biologics
- Provide strategic guidance on combination product development
- Develop pre-Request for Designations (pre-RFDs) and Request for Designations (RFDs)
- Nonclinical and animal program review and strategic support for FDA submissions
- Evaluation of safety profile for medical devices and biologics for purposes of starting an IND or IDE
- Review preclinical and animal protocols for regulatory consistency and compliance
- Preparation and review of FDA submissions
- Work directly with core testing labs on the execution of protocols
- Chemical characterization and Biocompatibility strategy
- Develop scientific overview and assessment of preclinical, biocompatibility, CMC, and animal program for regulatory purposes