SERVICIOS
Our Offer
Altus Trece offers a wide range of specialized consulting services, highlighting the design of regulatory strategies and the management of scientific research in close collaboration with health authorities.
Regulatory COFEPRIS and related areas
Research protocols for new molecules
Design and supervision of clinical/preclinical research plans, compliance with COFEPRIS regulations and ICH guidelines, and preparation of documentation for ethics committees and regulatory authorities to evaluate and approve studies.
Dossier assembly and pre-resolution:
Compilation, structuring, and submission of complete regulatory dossiers (pharmaceutical reports, quality, safety, and efficacy data), with pre-resolution strategies before COFEPRIS to resolve observations before the formal request.
GMP Certification
Implementation, validation, and auditing of GMP-compliant manufacturing systems; preparation of evidence and documentation for COFEPRIS and international authority inspections; and support in obtaining/renewing plant and laboratory certifications.
Facilitación de registro sanitario para fármacos y equipos médicos
Comprehensive support for obtaining health registrations, import notices, equivalencies, and compliance with NOMs and COFEPRIS guidelines for pharmaceutical products and medical devices.
Development of authorized third-party laboratories
Consulting for the creation and accreditation of authorized third-party laboratories, including quality plans, accreditations (ISO/IEC standards), operating procedures, calibration, and validation of analytical methods.
Health licenses for storage of controlled substances
Management of permits and licenses required for the storage, custody, and distribution of regulated substances, including security measures, inventories, and reporting to COFEPRIS.
Bioavailability/bioequivalence studies
Bioavailability/bioequivalence studies: design, execution, and reporting of bioequivalence studies in accordance with COFEPRIS/ICH guidelines, including protocols, statistical analysis, results interpretation, and approval dossiers.
Recognition of orphan drugs
Consulting for the classification, registration, and approval of orphan drugs, including financing strategies, incentive frameworks, and post-marketing surveillance requirements.
Services aimed at the pharmaceutical industry and hospital services
Recognition of orphan drugs
Rapid access routes, regulatory compliance for hospital use, and coordination of approval processes for dispensation in healthcare institutions.
Registration and permit strategies for the import/export of drugs and medical devices for hospitals
Customs management, temporary import permits, and NOM/FO compliance.
Audit management and responses to observations
Preparation of effective responses to COFEPRIS requirements, cross-audits with regulatory entities and institutional clients, and corrective action plans (CAPA).
Change management and license maintenance
Continuous review of changes in processes, formulation, and packaging, and updating of health licenses to ensure continuity of hospital supply.
Change management and license maintenance
Support in pharmacovigilance and product safety: design of pharmacovigilance plans, management of adverse event reports, and compliance with COFEPRIS reporting requirements for pharmaceutical products and medical devices.