The Guiding Principles in the Regulatory Affairs Steps for Latin America.

At ESTERN Medical, our regulatory and safety guidance oversight services are a seamless part of the drug development process from beginning to end.

Our regulatory have broad track record experience and a rapport with many Latin American regulatory agency divisions, that let us explore options with customers to succeed shortest route of their clinical trials and timeframe to bring their products to market.

It’s about having experience with the Latin American, FDA and the European regulatory authorities, so we can explore with you the most efficient route and shortest timeframe to market. It’s therapeutic area expertise. It’s understanding regulations, such as Common Technical Document (CTD) requirements or the European Clinical Trial Directive.

We know what issues are likely to come up and can develop strategies to address them early on. In addition, our knowledge of local market requirements throughout Latin American countries and specific regions in Latin America gives you the advantage of submitting registration applications simultaneously in any regions that interest you.

We begin with a strategic regulatory, scientific, and safety planning in the clinical trial phase that you will be launching. And collaborate in the designing a study that integrates a full understanding of the current regulations and the regulatory environment from the start to completion of your study, we can help you ensure that the complete drug development process will run more smoothly and efficiently.

ESTERN Medical also provides Business Science coordination and of clinical and post-marketing studies throughout Latin America.