Global Focus . . . Integrating
MEDICAL CONSULTING is a medical regulatory and clinical affairs
consulting company specializing in regulatory sciences, clinical
trials, and quality systems for the medical device industry worldwide.
We are focused specifically on medical devices and combination
products containing a medical device component.
specialties are FDA and global submissions, development and management
of international clinical trials, and FDA inspections.
Our specialty is providing semi-virtual networks for conducting
domestic and global clinical trials. We firmly believe this is
the new business
model that allows trials to run lean and minimize costs.
We have a business perspective and know economics drives multinational
What We Do
We create cost-effective, realistic and timely strategic plans
for regulatory approvals and then implement and manage them
product phases - from conception to completion.
We develop a unique regulatory strategy for each product, including
a step-by-step pathway to approval.
use our knowledge of the unique requirements of national and
international agencies to efficiently prepare regulatory
and their respective submissions.
have the expertise to integrate scientific, medical, regulatory
and clinical practice concepts and requirements into a
single program for your product.