Regulatory Affairs in Clinical Trials in Mexico

Clinical Trials in: Mexico, Argentina, Colombia and Brazil.

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As a leading CRO in LATAM, we specialize in supporting clinical trials throughout the region. Our extensive experience and broad network of clinical sites enable us to execute trials with speed and efficiency, ensuring high patient recruitment and retention rates.

Regulatory Affairs in Clinical Trials in Mexico

Regulatory Affairs in Clinical Trials in Mexico – Clinical Research LATAM

Regulatory affairs play a crucial role in the realm of clinical trials, ensuring that pharmaceutical products are developed and tested in compliance with rigorous standards and regulations.

In Mexico, a country with a rapidly evolving healthcare landscape, the regulatory environment for clinical trials is of paramount importance. This blog explores the key aspects of regulatory affairs in clinical trials in Mexico, shedding light on the processes, challenges, and opportunities involved in bringing new drugs to market.

The Regulatory Landscape in Mexico:

Mexico has made significant strides in harmonizing its regulatory framework with international guidelines, such as those established by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

The Federal Commission for Protection against Sanitary Risk (COFEPRIS) is the regulatory authority responsible for overseeing clinical trials and ensuring compliance with applicable laws and regulations.

Clinical Trial Authorization Process:

Before initiating a clinical trial in Mexico, sponsors are required to obtain authorization from COFEPRIS. The process involves the submission of a comprehensive dossier containing information about the investigational product, study protocol, patient safety measures, and ethical considerations.

COFEPRIS reviews the application and grants authorization if all requirements are met, ensuring the trial is conducted ethically and with proper patient protection.

Ethical Considerations and Informed Consent:

Ethics committees, known as Comités de Ética en Investigación (CEIs), play a vital role in safeguarding the rights and welfare of trial participants. These committees review study protocols, informed consent forms, and other relevant documents to ensure compliance with ethical standards.

Informed consent, obtained from participants before their enrollment, is a critical component that emphasizes transparency and protects their rights to make autonomous decisions.

Regulatory Affairs in Clinical Trials in Mexico

Regulatory Affairs in Clinical Trials in Mexico

Pharmacovigilance and Safety Reporting:

In Mexico, pharmacovigilance, the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any drug-related problems, is an essential aspect of regulatory affairs. Sponsors and investigators have a responsibility to promptly report any adverse events or unexpected reactions occurring during the clinical trial.

This proactive approach helps ensure participant safety and contributes to the overall assessment of the investigational product’s benefit-risk profile.

Post-Approval Obligations:

Once a clinical trial is successfully completed, and if the results are positive, sponsors can proceed with the regulatory approval process for marketing authorization.

In Mexico, this involves submitting a New Drug Application (NDA) or a Biologics License Application (BLA) to COFEPRIS. The authority assesses the data generated during the clinical trials, evaluates the product’s safety, efficacy, and quality, and grants market approval if all requirements are met.

Regulatory Challenges and Opportunities:

While Mexico has made significant progress in streamlining its regulatory processes, challenges still exist. Delays in approval timelines, resource limitations, and lack of harmonization between regulatory bodies are among the challenges faced by sponsors and regulatory affairs professionals.

However, these challenges also present opportunities for stakeholders to collaborate, strengthen regulatory frameworks, and enhance the efficiency of clinical trials in Mexico.

Collaborative Initiatives and Regulatory Harmonization:

To address the challenges faced in regulatory affairs for clinical trials, various collaborative initiatives and regulatory harmonization efforts are underway in Mexico. The country has been actively involved in regional and international collaborations, such as the Pan American Network for Drug Regulatory Harmonization (PANDRH) and the ICH. 

These initiatives aim to promote regulatory convergence, facilitate knowledge exchange, and improve the efficiency of regulatory processes.


Regulatory affairs in clinical trials form the backbone of drug development, ensuring patient safety, scientific rigor, and adherence to ethical standards.

In Mexico, the regulatory landscape is evolving to align with international guidelines, allowing for the development and evaluation of novel therapies. As the country continues to make advancements in its regulatory processes, stakeholders must remain vigilant, embrace collaboration, and work towards a common goal of fostering innovation while safeguarding public health.

Through a robust regulatory framework, Mexico can contribute significantly to the global clinical research landscape, ultimately benefiting patients worldwide.

Regulatory Affairs in Clinical Trials in Mexico

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Regulatory Affairs in Clinical Trials in Mexico

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We define ourselves as a unique team, capable of blending our academic background with a global business mindset to bring the highest standard of quality and operational excellence into clinical research in Latin America.

Early Phase Trials

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Medical Devices

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Regulatory Affairs in Clinical Trials in Mexico

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Unlock the advantages and opportunities of outsourcing clinical trials to Latin America. Diverse patient population, streamlined regulations, and cost-effectiveness

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From lower labor costs to lower costs for rent, utilities, and equipment, you can save money on your clinical trial budget while still ensuring the quality of your trial

Access to Emerging Markets

Latin America offers access to emerging markets, providing an opportunity for pharmaceutical companies to expand their reach and reach new patient populations.

Regulatory Affairs in Clinical Trials in Mexico

Cohortias is redefining Clinical Research in Latin America

We are committed to become leaders in providing clinical research services in Latin America. Here at Cohortias, we combine our academic roots, proven experience and a large pool of patients from an extensive network of sites.

Our main purpose is to deliver high quality data.

Regulatory Affairs in Clinical Trials in Mexico

Clinical Research in Latin America

Cohortias has built an extensive and highly reputable network of clinical sites which can access patients in a timely manner and operate within a standard-of-care comparable to the U.S. healthcare system.


  • Site Management

  • Data Management

  • Site Selection

  • Regulatory Submissions

  • Clinical Monitoring

  • Protocol Development


Beta Trials Platform

  • First-in-human studies

Medical Devices

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Phases I – III

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  • Diabetes/Metabolic Syndromes
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Regulatory Affairs in Clinical Trials in Mexico

Clinical Research in Latin America

Academic Leadership and Extensive Clinical Site Network for Efficient Clinical Trials

  • Our peer-to-peer management approach guarantees high patient recruitment and retention in any clinical trial

High Speed Execution

  • We offer the quickest start-up times in each country.
  • Efficient Clinical Site Selection and Contracting.
  • Benefit from our extensive network of clinical sites and streamlined contracting process.

Operational Excellence

  • Proven record of delivering rescue studies, we consistently exceed industry performance standards.
  • Our team provides efficient query resolution to keep your trial on track.

Business Insight and Flexibility

  • We offer innovative pricing models and short lines of communication to ensure maximum flexibility and cost-effectiveness.
  • At Cohortias, we prioritize  short lines of communication to ensure efficient collaboration.
  • Swift adaptation to changes in the trial landscape to keep your study on schedule.

Regulatory Affairs in Clinical Trials in Mexico

We provide our services with offices in:

Colombia &

Daniela Maresca
Daniela Maresca | Country Lead Argentina
Martín Hernández-Torre | CMO
Maritza Rojas | CRA II
Pedro Alvarez | Business Development Manager
Samantha Rodriguez Cohortias
Samantha Rdz. | Start-Up Manager
Regulatory Affairs in Clinical Trials in Mexico

The Cohortias Team

Regulatory Affairs in Clinical Trials in Mexico

As the largest South American Contract research Organization, we know the Advantages and Challenges Of the Region

Let Us Guide You Through The Latin American Clinical Research Landscape

Regulatory Affairs in Clinical Trials in Mexico

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