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Regulatory Affairs

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

Our regulatory team has broad track record experience and a rapport with many US North America and 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 within US FDA, Latin American 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 US, LATAM & 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 US and Latin American countries in key specific regions in Latin America that will give 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 Regulatory Affairs team has daily-use knowledge of regional regulatory requirements across the globe. We offer competitive product development plans, rapid study startup and effective submissions strategies. This is possible through close collaboration with multi-functional project teams that support Early Clinical Trial Development, Product Registration and Late Phase trials. Our partnership with ESTERN Medical Analysis & Reporting and Safety & Risk Management groups has proven instrumental in ensuring successful development programs.

We provide international consulting services and develop strategies for the registration of clinical trials for:

  • Novel products
  • Biotechnology therapeutics
  • Advanced therapeutics for a broad range of products:
  • New chemical entities
  • Biologicals
  • Medical devices

 

Our teams have scientific backgrounds and other significant experience from:

  • Pharmaceuticals, Biotechnology and Medical Device Companies
  • Other CROs
  • Regulatory Agencies
  • Academic Institutions

 

ESTERN Medical offers the following regulatory services covering all aspects from discovery to all phases of clinical development, to market approval, and leading into the post marketing studies:

  • Regulatory lifecycle management
  • Regulatory strategic development
  • IND/ NDA/ CTA/ 510K/ PMA submissions/maintenance
  • Orphan Applications
  • Agency meeting preparation
  • Marketing authorization applications
  • Agency Liaison