A healthcare and life sciences lawyer supports pharmaceutical, biotech, medical device, cosmetics, food and beverage, supplement, agrochemical and healthcare services companies across their entire relationship with the regulator: from registering a product to defending against the shutdown of a facility.
At KNR Abogados we cover that full cycle in Mexico — regulatory prevention, filings before COFEPRIS and administrative litigation — with one goal: turning Mexico's regulatory framework from an obstacle into a strategic advantage for entering, growing and operating with certainty.
Regulatory compliance: acting before the inspection
In sectors governed by the General Health Law, the cost of non-compliance is rarely just the fine: it is the seized product, the halted production line or the closed facility while the operation keeps burning cash. That is why the work starts before the authority knocks, with internal audits that measure plants, laboratories, clinics and distribution centers against the applicable Mexican Official Standards (NOMs).
The same preventive logic applies to the product itself: a regulatory risk matrix surfaces contingencies before launch, while fixing them is still cheap, and reviewing labeling, packaging and advertising keeps a campaign from being pulled after the media buy. In digital health — telemedicine, electronic medical records, sensitive data processing — exposure now matters as much as the sanitary side, and deserves the same rigor.
COFEPRIS filings and dealing with the authority
Day-to-day operations in life sciences depend on specific authorizations: sanitary registration of medicines, biologics and medical devices, along with their amendments, renewals and assignments; the facility’s sanitary license or notice of operation; prior import permits for health supplies, raw materials and biological samples; and advertising permits for health products and medical services.
Each has its own authority, technical file and timeline. We handle the full filing and hold the conversation with COFEPRIS and, where the product requires it, with SADER and SENASICA — and we structure the pharmacovigilance and technovigilance plans the regulatory framework expects to be alive and running, not merely documented.
Inspections, precautionary measures and defense
An inspection is won or lost in the official record. We accompany the visit technically and legally in real time — before COFEPRIS or state commissions such as COPRISEM or COPRISJAL — so that what is written down reflects what actually happened, because that document becomes the foundation of everything that follows.
Once a measure is in place, the focus is returning the business to normal: seeking the release of seized product, the lifting of suspensions or closures, and challenging fines, license revocations and adverse rulings through administrative appeal, nullity proceedings before the Federal Court of Administrative Justice (TFJA) or amparo. Deadlines run from the moment of notice, so the first call matters.
This content is informational and does not constitute legal advice. Every case requires individual analysis.
Internal sanitary audits
Preventive assessment of operations, plants, laboratories, clinics and distribution centers to verify compliance with the Mexican Official Standards (NOMs).
Regulatory risk matrix
Identification, analysis and mitigation of legal contingencies before launching or marketing products in Mexico.
Labeling and advertising review
Regulatory validation of advertising projects, packaging, informative labeling and marketing campaigns under the General Health Law and its regulations.
Data protection and digital health
Legal counsel on telemedicine, electronic medical records and the privacy of sensitive data in the healthcare industry.
Sanitary registrations
Obtaining, amending, renewing and assigning registrations for medicines, biologics and medical devices.
Licenses and notices of operation
End-to-end handling of authorizations to open and run healthcare facilities, pharmacies, warehouses, manufacturing plants and laboratories.
Import and export permits
Prior import permits for health supplies, raw materials, biological samples and finished products.
Advertising permits
Filing and follow-up before the authorities for the authorized promotion of health products and medical services.
Pharmacovigilance and technovigilance
Counsel on structuring and implementing risk management plans under the applicable regulatory framework.
Support during inspections
Technical and legal support in real time during sanitary inspections by COFEPRIS or state bodies (COPRISEM, COPRISJAL, among others).
Defense against precautionary measures
Immediate legal strategies to lift product seizures, suspension of activities or closure of facilities.
Administrative appeals
Legal representation against fines, license revocations and adverse rulings issued by the health authority.
Nullity proceedings and amparo
Contentious defense before the Federal Court of Administrative Justice (TFJA) and the Federal Judiciary to safeguard the company’s operations and assets.
Your questions, answered
Which products need a COFEPRIS sanitary registration?
Health supplies — medicines, biologics and medical devices, among others — require sanitary registration before they can be marketed. Other products, such as food, supplements or cosmetics, follow a different route centered on the notice of operation, labeling and advertising. Classifying the product correctly is the first step: it determines the filing, the technical file and the timeline of the whole project.
What is the difference between a sanitary license and a notice of operation?
A notice of operation informs the authority that a facility is starting to operate; a sanitary license is an authorization that must be obtained before operating and is required for higher-risk activities, such as manufacturing medicines. Choosing the wrong one is among the most common causes of suspension of activities.
Do I need a permit to advertise a health product or service?
It depends on the product and the audience of the campaign: some advertising of health supplies and medical services requires a prior permit, and the rest must still meet content requirements even where no authorization is filed. Reviewing the piece before the media buy avoids suspension orders and penalties that usually cost more than the fix.
COFEPRIS suspended my facility. What can I do?
There are routes to request that the measure be lifted and to challenge the underlying ruling. The first step is gathering the inspection record and the technical file, because the defense is built on what was written down during the visit. Deadlines run from the date of notice and are short, so it is best to act immediately rather than wait for a final resolution.
What does the authority check during an inspection?
The visit focuses on whether operations match what was authorized: licenses, notices and registrations in force, sanitary conditions of the facility, documentation and traceability controls, product labeling and compliance with the NOMs applicable to the activity. The record signed at the end is the key document, which is why legal support belongs during the visit, not after it.
What is pharmacovigilance, and who must comply?
It is the set of activities for detecting, assessing and preventing adverse effects of medicines; technovigilance does the same for medical devices. It reaches registration holders, manufacturers, distributors and healthcare facilities, which must keep a risk management plan verifiably running, not merely written.
Anticipate. Protect. Scale.
Free legal assessment
Answer a short questionnaire (under 2 minutes) and our team will send you an assessment of your compliance and a strategic proposal for your operations in Mexico.
Does your company need counsel in this area?
Tell us what is happening and we will tell you whether it is a matter we can take on, what it would involve, and how the scope is defined.
A lawyer will review your matter and confirm the next step within 24 business hours.