Clear labels, clear compliance. We translate regulations into certainty.
Labeling & Packaging Compliance (Marbete Review Services)
Accurate labeling is one of the most critical elements of health-product regulation.
Pharmacounselors® offers specialized label and artwork review services (commonly known as Marbete Revision) to ensure that your product presentation, claims, and information fully comply with Mexican health regulations and applicable NOM standards before COFEPRIS authorization or product commercialization.
Our multidisciplinary team — composed of regulatory specialists, pharmacists, and lawyers — reviews every aspect of your labeling to prevent observations, rejections, or administrative sanctions.
Our Labeling & Compliance Services include:
- Comprehensive review of labels, boxes, inserts, and artwork to meet COFEPRIS and NOM requirements.
- Verification of mandatory health information, warnings, lot/batch data, and expiration details.
- Claims and promotional language validation to ensure compliance with advertising and health-law restrictions.
- Harmonization of labeling for multi-country LATAM submissions, guaranteeing linguistic and regulatory consistency.
- Legal verification of symbols, logos, and pictograms used on packaging.
- Pre-approval and advisory before printing or importation.
- Continuous monitoring of regulatory updates that affect labeling criteria.
Objective:
To guarantee that every product entering the Mexican and LATAM markets communicates the correct, compliant, and authorized information — protecting both the consumer and the company’s legal security.
Tagline:
Clear labels, clear compliance. We translate regulations into certainty.
PharmaCounselors® International 