Contact


Jesús Loureiro PhD

Medical Writer and Scientific Advisor

Regulatory

Navigating the regulatory landscape in the medical and pharmaceutical industries requires meticulous attention to detail and a deep understanding of regulatory requirements. My extensive experience in medical writing includes the preparation of high-quality regulatory documents that comply with international standards and guidelines.
  • Clinical Study Reports (CSRs): Comprehensive reports detailing the methodology, results, and conclusions of clinical trials.
  • Investigational New Drug Applications (INDs): Detailed applications required to obtain approval for initiating clinical trials.
  • New Drug Applications (NDAs): Complete documentation necessary for the approval of new pharmaceuticals.
  • Common Technical Documents (CTDs): Standardized formats for regulatory submissions, including quality, safety, and efficacy information.
  • Patient Safety Narratives: Concise and clear descriptions of adverse events in clinical trials.
Services

Consensus

Scientific

Regulatory

Marketing

Advisory boards

Congress


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  0034 675933513
 jesusloureiro@gmail.com
 Madrid, Spain