Drug Development in Mexico

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

Locally-Based, Full Service CRO

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Sites Throughout LATAM
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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.

Drug Development in Mexico

Drug Development in Mexico – Clinical Trials in Latin America

Drug development is a complex and multi-stage process that involves the discovery, development, and testing of new drugs. This process typically takes several years and requires significant financial investment, research and development, regulatory approval, and clinical trials.

Drug development in Mexico is a rapidly growing industry that plays a critical role in advancing healthcare and improving the quality of life for patients.

Mexico is home to a diverse and rapidly growing pharmaceutical industry. According to the Mexican Association of Pharmaceutical Research Industries (AMIIF), the industry has experienced steady growth over the past decade, with the market value of pharmaceutical products reaching $22.8 billion in 2020.

Mexico is also home to several large pharmaceutical companies, including Sanofi, Pfizer, and Bayer, which have a strong presence in the country and invest heavily in drug development.

The drug development process in Mexico begins with the discovery of new compounds that have the potential to treat or cure diseases. This process typically involves screening large libraries of compounds to identify those with the desired therapeutic properties. Once a potential drug candidate has been identified, it must undergo extensive preclinical testing to ensure that it is safe and effective.

Preclinical testing typically involves testing the drug candidate in animal models to evaluate its pharmacokinetics, toxicity, and efficacy. This process can take several years and requires significant financial investment, as well as expertise in toxicology, pharmacology, and other areas of biomedical research.

Once a drug candidate has successfully completed preclinical testing, it must undergo clinical trials to evaluate its safety and efficacy in humans. Clinical trials are typically conducted in three phases, each of which involves progressively larger groups of patients and increasingly rigorous testing protocols.

Phase 1 clinical trials are designed to evaluate the safety and pharmacokinetics of the drug candidate in a small group of healthy volunteers. Phase 2 clinical trials are designed to evaluate the safety and efficacy of the drug candidate in a larger group of patients with the target disease.

Drug Development in Mexico
Drug Development in Mexico

Drug Development in Mexico

Finally, phase 3 clinical trials are designed to confirm the safety and efficacy of the drug candidate in a large group of patients and to compare it to existing treatments or placebo.

Clinical trials in Mexico are subject to strict regulatory oversight by the Federal Commission for Protection against Sanitary Risks (COFEPRIS). COFEPRIS is responsible for ensuring that clinical trials are conducted in accordance with ethical and scientific standards, and that the data generated by these trials are reliable and accurate.

Once a drug candidate has successfully completed clinical trials, it must be submitted to COFEPRIS for regulatory approval. This process typically involves a thorough review of the clinical trial data, as well as a review of the manufacturing process and labeling information.

Regulatory approval in Mexico can be a lengthy and complex process, as it requires compliance with a variety of national and international regulations and standards. However, once a drug has been approved by COFEPRIS, it can be marketed and sold in Mexico, providing patients with access to new treatments and therapies.

In addition to drug development and regulatory approval, Mexico is also home to a thriving pharmaceutical manufacturing industry. This industry produces a wide range of pharmaceutical products, including generic drugs and branded medications, which are distributed both domestically and internationally.

The pharmaceutical manufacturing industry in Mexico is highly competitive and has attracted significant investment from multinational pharmaceutical companies. These companies have established manufacturing facilities in Mexico to take advantage of the country’s skilled workforce, favorable regulatory environment, and strategic location.

The pharmaceutical industry in Mexico is also supported by a strong research infrastructure, which includes several leading academic and research institutions, as well as government agencies and non-profit organizations. These organizations provide funding, training, and support for drug development and clinical research, as well as for the translation of research findings into clinical practice.

Overall, drug development in Mexico is a rapidly growing and highly competitive industry that plays a critical role in advancing healthcare and improving patient outcomes.

Drug Development in Mexico

Source: Roche

Cohortias the CRO of LATAM

Welcome to Cohortias!

of Latin America

Simplify Your Clinical Trials with Our Expert Infrastructure in Latin America

Say goodbye to the complex, costly, and disorganized process of conducting clinical trials. Our infrastructure in Latin America streamlines the launch of studies and ensures adherence to international standards. Schedule a call with us today to discover the path to simplified clinical research in Latin America.

Drug Development in Mexico

Explore What We Are Doing Better

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

- First-in-Human Studies.
- Get to patients faster, no IND necessary.
- Valid data for FDA submission.

Rescue Studies

- Regain lost time and boost patient recruitment.
- We work alongside Global CROs to get studies back on track.
- More than 200 sites available.

Phase II & III Trials

- Full-Service Clinical Outsourcing.
- Proven infrastructure that can handle any trial.
- Local Regulatory Experts
- Wide network of sites and physicians.

Medical Devices

- A fast-track platform that will meet your timeline.
- We take care of everything, from shipping requirements all the way to data collection.
Drug Development in Mexico

Full Service CRO in LATAM

Outsourcing Clinical Trials to Latin America

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

Lower Operating Costs

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.

Drug Development 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.

Drug Development 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

  • Pilot and Pivotal Device Studies

Phases I – III

  • We partner with our clients to bring their products in a fast and efficient manner to the market with the highest quality standards


  • Diabetes/Metabolic Syndromes
  • Infectious Diseases
  • Cardiovascular
  • Neurology
  • Respiratory
  • Oncology

Drug Development 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.

Drug Development 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
Drug Development in Mexico

The Cohortias Team

Drug Development 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

Drug Development in Mexico

Network & Partnerships