Overview

MCRA's world class team and >100 integrated services allows for us to be the #1 partner to assist you in unlocking value.

US Regulatory

MCRA is the leading U.S. Regulatory Advisor for the Medical Device and Biologics industries. Our deep bench of talent in virtually every discipline creates value and mitigates risk by combining  unparalleled comprehension of FDA laws and regulations. MCRA both advises and implements all types of strategies and FDA submissions.

International Regulatory

Our expansive experience with international regulatory bodies across a number of device technologies enables us to help clients operate, expand, and achieve long-term business objectives in global markets.

Quality Assurance

We understand that medical device companies must adhere to strict FDA and international quality assurance requirements to ensure product consistency and safety.

Healthcare Compliance

An effective healthcare compliance program is a fundamental business requirement for any healthcare organization.