ABOUT US

Your strategic allies in regulatory affairs


At ERRE, we specialize in regulatory projects with COFEPRIS (Mexico’s health authority).

With over a decade of experience across the pharmaceutical, medical device, hospital, cosmetics, and dietary supplement sectors.
More than a consultancy, we become strategic partners supporting each client throughout the entire regulatory process and ensuring their projects translate into concrete, sustainable results.
Our commitment is clear: to make your regulatory path simpler and more efficient, so you can focus on what truly matters—growing your business.

+175

Satisfied Clients

+10

Years of Experience

100%

Effectiveness

OUR DIFFERENTIATOR

Big advantages when you choose us

Beyond our services, we offer the confidence of a team that works with agility, strategy, and complete focus on your company’s success and savings.

Expert, multidisciplinary talent

We have a team of professionals across different fields, ready to tackle any challenge.

Agile response times

Our structure allows us to react and address your needs quickly, so your projects keep moving .

Strategic project design

We offer solutions designed to prepare you and give you a competitive edge—today and tomorrow.

Processes designed to save time and costs

Maximum optimization. Our internal processes and project execution are designed to cut downtime and unnecessary expenses, benefiting your budget.

100% tailor-made solutions

We understand every business is unique. We create strategies and tools specifically for your company’s challenges, goals, and size.

Technical expertise and strategic projects that guarantee results

We combine deep technical experience with solid strategic planning to give you the confidence you’ll get what we promise.

READY TO MOVE FORWARD?

Receive a regulatory roadmap and estimated timelines for your case.

OUR SERVICES

custom regulatory strategies

From GMP certificates to registrations, licenses, and advertising approvals, we design comprehensive, customized regulatory solutions.


Good Manufacturing Practices (GMP) Certificate

We support your company in meeting manufacturing standards, ensuring quality processes that pass COFEPRIS inspections.

• Facility design for health-product manufacturing processes.
• Implementation of Quality Management Systems in accordance with current standards.
• Strategic planning and consulting to achieve GMP compliance.
• Staff training to prepare for inspection visits.

Sanitary Licenses

We streamline the acquisition of key licenses for the safe, regulated operation of your company in the health sector.

• Sanitary license for manufacturing health products.
• License for pharmaceutical storage.
• Sanitary licenses for hospitals, clinics, and surgical procedures.

Registration of Medicines and Medical Devices

We guide you through the entire process of registering, modifying, or renewing products with the health authority, ensuring certainty and speed.

• Dossier preparation for new registrations, technical or administrative modifications, and renewals.
• Sanitary registrations, modifications, and renewals.
• Regulatory feasibility studies.

Health Advertising Notices and Permits

We support your campaigns and digital platforms so they communicate safely and comply with regulatory guidelines.

• Authorizations for websites.
• Authorizations for social networks
• Authorizations for marketing campaigns.

Training programs

We develop teams prepared to comply with health regulations.

• Training programs tailored to your company’s regulatory objectives.

COFEPRIS Fines

We have teams prepared to ensure regulatory compliance and provide legal defense for companies facing sanctions.

• Legal team to litigate fines imposed by COFEPRIS.


OUR EXPERIENCE

Sectors we’ve worked in

We work closely with industries that demand precision, quality, and trust. Discover where we’ve made our mark!

PHARMACEUTICAL

Certificates, licenses, and production facility design.

MEDICAL DEVICES

Registrations and validations with COFEPRIS.

HOSPITAL

Licenses and comprehensive sanitary compliance.

PRODUCTS

Regulated notifications, labeling, and advertising for cosmetics and supplements.

CONTACT

Tell us about your project

Our team is ready to guide you and design the best regulatory strategy for your company.

CONTACT INFORMATION