Creating bridges, support better lives.
About Us
We promote productive growing and international market integration through free market of specialized products and services.
We offer international trading solutions, facilitating your operation through support of
pre-qualified Mexican and LATAM companies that can offer you a quality service all through your supply chain.
These services may include: Pre-Evaluation, Development of Commercial-Regulatory Strategy, Quality Management System Compliance, Implementation and support during the process.
Invest attraction. Technology Transfer. Compliance Training. Product Certification.
Acerca de Nosotros
Promovemos el crecimiento productivo y la integración de mercados internacionales a través del libre comercio de productos y servicios especializados.
Ofrecemos soluciones en comercio internacional, facilitando su operación por medio de empresas mexicanas y latinoamericanas precalificadas por nosotros, quienes pueden ofrecer servicios de apoyo con calidad durante la cadena de suministro.
Estos servicios pueden incluir: Pre-Evaluación, Desarrollo de la Estrategia Regulatoria-Comercial, Cumplimiento del Sistema de Gestión de Calidad, Implementación y Apoyo durante el proceso.
Atracción de Inversionistas. Transferencia de Tecnología, Entrenamiento en Compliance, Certificación de Producto.
Our Mission
Strengthen commercial bridges between countries to improve the quality of life of their populations through the regulated trade of quality goods and services.
Nuestra Misión
afianzar los puentes comerciales entre paises para mejorar la calidad de vida de sus poblaciones mediante el comercio regulado de bienes y servicios de calidad.
Value
+9 years in market compliance.
Specialists in Health Products. Science and Regulation Experts.
Connect Pre-Qualified Companies.
Valor Agregado
+10 años en regulación de mercado. Especialistas en Productos para la Salud. Expertos en Ciencias y Regulación.
Conecte con Empresas Pre-Calificadas.
About me
Sobre mi
玛丽亚 Denisse Rojas
Pharmaceutical Biological Chemist, bachelor – Metropolitan Autonomous University (UAM).
Healthcare Management, master’s degree – Valley of Mexico University (UVM).
ISO 13485 Leader Auditor – BSI.
+10 years of experience in Market Access. GxP. QA/RA. Import/Export
Warehouse Management. Distribution Technovigilance. Conformity Assessment, Compliance.
COFEPRIS authorized signature for review drugs and medical devices dossier.
Technical Expert in Medical Devices for ema.
ISO 9001, ISO 14001, ISO 45001, ISO 17021, ISO 17025, ISO 15189.
María Denisse Rojas
Químico Fármaco Biólogo, Licenciatura – Universidad Autónoma Metropolitana (UAM).
Gestión Directiva en Salud, Grado de Maestría – Universidad del Valle de México (UVM).
Auditor Líder, ISO 13485 – BSI.
+10 años de experiencia en Acceso a Mercado. BPF (NOM 059, ISO 13485, NOM 241). QA/RA. Importaciones / Exportaciones. Manejo de Almacenes. Distribución. Tecnovigilancia. Evaluación de la Conformidad, Compliance.
Signatario autorizado por COFEPRIS para revisión de dossier para medicamentos y dispositivos médicos.
Experto Técnico en Dispositivos Médicos y Salud por la ema.
ISO 9001, ISO 14001, ISO 45001, ISO 17021, ISO 17025, ISO 15189.
Creating bridges, supporting better lives.
the most efficient and safe way to access the market.
Quality Management System Compliance.
Good Manufacturing Practices.
Invest attraction.
Technology Transfer.
Our Services / Nuestros Servicios
Pre-Evaluation
Diagnosis, let us know about your project. Set the scope of the project.
Development of Commercial-Regulatory Strategy
Depending of product nature may include:
· RA/QA Consulting.
· Product Classification, Requirements to fulfill, Compliance.
· Device Registration.
· Dossier compilation, Pre-Review according to Authorities’ Checklist.
· In-country representation and Product Mgmt.
· Holder, Legal Representative.
· Warehouse, Sanitary Responsible.
· Customs Agents.
· Distribution & Logistics.
· Post-market surveillance.
· Product traceability.
Product Verification / Certification
· Drugs.
· Medical Devices.
· Food supplements.
· Cosmetics.
· Home & Office Products.
· Electronics & Home Appliances.
· Fresh fruits.
· Photovoltaic cells.
Compliance Training
· Mexican.
· International.
Get In Touch
Sale in México! Ready for the Next Step?
Contact us, let us know about your challenges!
Your name, country, and any other information you provide in this contact form, such as email, and phone number are held in strict confidence. We do not sell or share your information with anyone else.