Good Laboratory Practice Standards

MQI provides leadership to assure a preclinical development plan that is compliant with regulatory guidelines for drugs and medical devices. We plan and implement preclinical studies, an important first step in the development of new products.

We have a stepwise plan for preclinical development:

Step 1: A preliminary design for preclinical development

Step 2: Communication with FDA or other appropriate regulatory agencies about the development plan

Step 3: Agreement with, and consent from, regulatory agencies for the development plan

Step 4: Implementation of the preclinical plan

Step 5: Regulatory package (e.g., IND, IDE, 510k, 505 b(2),etc.) for submission to a regulatory agency to proceed to clinical investigation

Step 6: Clinical Studies