For Medical Devices Companies
ESTERN Medical guides medical device global companies to bring their Clinical Trials products to be market in the United States, Europe, Latin America and the world and most important efficiently and cost-effectively by providing the right clinical trial and regulatory strategy the first time.
In a world of challenging and dynamic regulations issues, it is essential to maintain your business with new product introductions.
This necessitates a robust system for handling clinical trials and regulatory issues as well as detailed knowledge of particular requirements. ESTERN Medical CRO, assists you in route you in to the proper US-North American or Latin America emerging markets success.
Our experts consist of former clinical, regulatory, reviewers from top international Biotech’s, Pharmaceutical, Medical Device and CRO global companies with broad global knowledge and key expertise across US-North America and Latin America.
Many of them have contributed in developing the pathways and guidelines issued in different US & Latin America Health Agencies.
We help you plan your clinical development and succeed with it.
We provide advice and support for preparation of 510k, IDE, PMA submissions and clinical trial complete execution.