SERVICES

Validation Systems

We ensure the reliability of your processes through documented evidence under the standards of the Master Validation Plan. 

Quality Systems

We implement and optimize robust Quality Management Systems (QMS) based on NOM-059 and ISO standards.

Storage Systems

We guarantee the integrity of your supplies by complying with Good Storage and Distribution Practices (GSPDP).

Regulatory Systems

We manage the lifecycle of your products with agencies such as Cofepris and the FDA. 

Personnel Management Systems

We optimize the management of technical talent by defining job profiles, competency matrices, and induction programs. 

Data Integrity

We protect the accuracy and traceability of your technical information under the ALCOA+ principles. 

Pharmacovigilance

We establish surveillance systems to monitor the safety and effectiveness of your medications. 

Medical Device Registration

We expedite the process of obtaining health registrations for medical devices, from diagnostic equipment to surgical materials.

Internal and Third-Party Audits

We conduct comprehensive assessments (internal or of suppliers) to identify compliance gaps and areas for improvement.

Staff training courses

We develop your organization's human capital with technical training programs in current regulations, GMP (Good Manufacturing Practices) and quality management.