Contact


Jesús Loureiro PhD

Partnering with Medical Affairs on publications, advisory boards, and evidence dissemination.
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

Medical Publications  

Manuscript development, journal selection, publication planning

Medical Advisory & Consensus  

Consensus and advisory board design, moderation, actionable insights

Regulatory & Clinical  

CSR summaries, clinical synopsis, medical review support

Congress Reporting

Detailed congress reports 

Marketing materials  and Scientific Dissemination

Creation and medical Review of promotional and communication materials

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  0034 675933513
 jesusloureiro@gmail.com
 Madrid, Spain