Our Cross-Disciplinary Approach

Our cross disciplinary approach, deep bench of talent in virtually every discipline, and contacts with U.S government agencies enables us to help clients operate, expand and achieve their long-term business objectives. MCRA merges best-in-class consulting and CRO clinical research practices.

CRO Clinical Trial & Research

Our team has built an established reputation by working to streamline the effectiveness and success of clinical trials for over a decade.

US Regulatory & FDA

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 Consulting

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.

Reimbursement

Today, reimbursement is the most complex and significantly changing dynamic in healthcare technology commercialization.

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.