ABOUT US
Our Mission
Altus Trece is a highly specialized consulting firm that stands out for its focus on designing regulatory strategies and managing scientific research in close collaboration with health authorities.
Our team of consultants is comprised of experienced researchers who base their knowledge on a solid scientific track record and a proven track record of results. This human capital is an essential advantage for navigating COFEPRIS's increasingly complex regulatory landscape, with its demanding access criteria and alignment with global standards.
We maintain a rigorous focus on continuous improvement of manufacturing processes and strict adherence to the evaluation criteria established by various regulatory and evaluation bodies.
SERVICES
Our Portfolio
We offer a wide range of services, including project design, research protocol development, medical device documentation generation, and GMP certification, among others. We maintain an evidence-based approach and guarantee customized solutions tailored to our clients' needs.
Value Proposition
Comprehensive regulatory strategy: from initial assessment to registration and licensing.
Evidence-based approach: development of protocols and documentation supported by data and best practices.
Compliance and quality: implementation of GMP systems, GMP aligned with ICH and international guidelines.
Project management and traceability: multidisciplinary coordination, risk management, and change control.
Collaboration with authorities: effective communication and transparency with COFEPRIS and other regulatory actors.
Tailor-made solutions: adaptability to the needs of device manufacturers, distributors, and suppliers.
Pillars of execution and added value
Comprehensive approach: from regulatory strategy to operational execution (documentation, audits, inspections, and post-registration follow-up).
Specific knowledge of COFEPRIS: interpretation of NOMs, ICH guidelines, and international frameworks applicable to the Mexican industry.
Risk and quality management: quality management systems, CAPA, change control, and robust traceability.
Efficient turnaround times: pre-resolution strategies, evidence gathering, and dossier preparation to expedite approvals.
Support for hospitals and healthcare services: Facilitate approval and access to pharmaceutical products and medical devices for hospital use, with regulatory compliance and safety standards.
