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Regulatory Affairs

Regulatory Training and Workshops

The right knowledge, for the right people, at the right time.

Regulatory compliance in clinical research is only as strong as the people responsible for it. Whether you are training site staff on GCP requirements, onboarding a sponsor team unfamiliar with COFEPRIS, or running a workshop on Mexican regulatory submissions, Althian delivers tailored training that is practical, current, and built for the real world.

In-person or virtual. For any audience. On any topic within our regulatory expertise — covering COFEPRIS, ANVISA, INVIMA, DIGEMID, and other LATAM health authorities.

Who We Train

Whoever needs it.

Our training programs are designed for any individual or team that works within — or alongside — the clinical research regulatory environment in Mexico and Latin America. We adapt the content, format, and depth to the specific needs of the audience.

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Site Staff
Investigators, coordinators, and site teams who need training on GCP, COFEPRIS requirements, protocol compliance, and regulatory documentation.
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International Sponsors
Sponsor teams entering the Mexican or LATAM market who need to understand local regulatory landscapes and how they differ from FDA or EMA requirements.
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Regulatory Teams
In-house regulatory affairs professionals who need to stay current on COFEPRIS, ANVISA, INVIMA, or DIGEMID updates, new guidance, or specific submission requirements.
Regulatory Training and Workshops

What We Cover

Training topics built around your needs.

Hover over each topic to learn more

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GCP Training
Comprehensive GCP training for investigators, coordinators, and site staff — aligned with ICH E6 guidelines and COFEPRIS requirements. Available in Spanish and English.
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COFEPRIS and LATAM Submissions
Practical workshops on navigating submission processes across COFEPRIS, ANVISA, INVIMA, and DIGEMID — including dossier preparation, DIGIPRIS, and health authority expectations.
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Bioethics and Compliance
Training on Mexican bioethics regulations, informed consent requirements, ethics committee processes, and patient protection standards.
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Compliance and Risk Management
Best practices for maintaining regulatory compliance throughout the product lifecycle, including GMP inspection readiness, CAPA development, post-marketing obligations, and internal audit preparation.
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LATAM Regulatory Landscape
For international teams entering LATAM — an overview of COFEPRIS, ANVISA, INVIMA, DIGEMID, and other key authorities, including differences from FDA and EMA and what to expect when operating in the region.
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Bilingual and Adapted Content
All training materials available in Spanish and English, adapted to local terminology, cultural context, and regional regulatory precedents for maximum relevance and impact.

Hover over each topic to learn more

Why Althian

We don't teach from a textbook.
We teach from experience.

Our trainers are the same people who manage COFEPRIS submissions, conduct site initiations, and navigate the Mexican and LATAM regulatory system every day. The knowledge we share in our workshops is not theoretical — it is built from 15 years of hands-on regulatory experience in the region.

Every training program we deliver is tailored to the audience, the context, and the specific regulatory challenges they face. Delivered by bilingual experts. Adapted for the real world.

Ready to bring your study to LATAM?

Tell us about your project. We'll make it happen.

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Monterrey, México

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