We ensure the reliability of your processes through documented evidence under the standards of the Master Validation Plan. We critically evaluate equipment, computerized systems, and manufacturing processes to guarantee consistent results that meet the required quality attributes.

We implement and optimize robust Quality Management Systems (QMS) based on NOM-059 and ISO 9001. We focus on risk management, change control, and continuous improvement to reduce operational errors and ensure the satisfaction of health authorities.

We guarantee the integrity of your supplies by adhering to Good Storage and Distribution Practices (GSDP). We monitor strict temperature, humidity, and cold chain controls, ensuring that products maintain their therapeutic efficacy until final delivery.

We manage the lifecycle of your products with agencies such as Cofepris and the FDA. Our consulting services cover everything from market entry strategy to maintaining extensions and modifications, transforming regulations into a competitive advantage for your business.

We optimize the management of technical talent by defining job profiles, competency matrices, and onboarding programs. We ensure that each employee has the necessary qualifications to operate in highly regulated environments.

We establish post-marketing surveillance systems to monitor the safety and effectiveness of your medications. We report and manage adverse events according to international guidelines, protecting patient health and your brand's reputation.