Specialized Services
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Navigate the Regulatory Environment with Certainty and Compliance.
Navigate the Regulatory Environment with Certainty and Compliance.
Strategic solutions.
Strategic solutions.
Why entrust its fulfillment to us?
Why entrust its fulfillment to us?
In a market where health regulations are constantly evolving, the difference between commercial success and an administrative penalty lies in technical precision.
Strategic Support
Strategic Support
Direct Experience with COFEPRIS: Expert management of health registrations, operating permits, modifications, and renewals. We understand current evaluation criteria to minimize issues.
Quality Management Systems (ISO 9001:2015): We implement processes that not only comply with the standard but also optimize your organization's efficiency.
Laboratory Accreditation (ISO/IEC 17025:2017): We ensure that your testing and calibration processes meet the highest standards of technical competence and validity of results.
Our Specialized Services
Our Specialized Services
Drug Regulatory Affairs: Technical dossiers, compliance with NOM-059 and NOM-073, management of new and generic drugs.
Medical Supplies and Devices: Risk classification, medical device registration, and compliance with NOM-241.
Diagnostic Audits: Preliminary assessment to verify your compliance level before an official inspection or certification.
Technical Training: Customized training for your team on current regulations and best practices.
The Value of Prevention
The Value of Prevention
Don't wait for an audit to discover gaps in your system. Strong compliance from the start reduces time to market and protects your brand's reputation.
Our Goal
Your only concern should be the growth of your business, while we ensure your regulatory compliance with a licensed professional.
Areas of interest
Validation Systems
Quality Systems
Storage Systems
Regulatory Systems
Training Courses
Audits
Medical Device Registry
Pharmacovigilance
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