Creating bridges, support better lives.
About Us
We are a consulting firm founded in 2017 and based in Mexico City.
Our team comprises multidisciplinary experts with over 30 years of combined
professional experience in international markets across the public and private sectors.
We focus on providing value-added business solutions for our clients.
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.
Value
+15 years in market compliance.
Specialists in Health Products.
Science and Regulation Experts.
Our team
Denisse Rojas
Founder – Senior Consultant, Healthcare Division.
– · –
15 years of experience in regulation of healthcare products and services.
ISO Lead Auditor, Technical Expert for the Mexican Accreditation Entity, A.C.
Former Authorized Third-Party Verifier for COFEPRIS (Federal Commission for Protection against Sanitary Risks).
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Brenda Ovalle
Founder – Junior Consultant, Health Division.
– · –
+5 years of experience in regulation of healthcare products and services.
Health Officer for establishments handling medications and medical devices.
Auditor, Instructor, and Implementer for NOM regulations and ISO Standards.
Technical Expert for the Mexican Accreditation Entity, A.C.
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Eduardo Mancilla
Founder – Senior Market Access Consultant.
– · –
15 years of experience in Quality Management, standardization, standards application,
energy management, metrology, compliance, product certification, risk management,
conformity assessment and NOM (Mexican Official Standards).
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.
Products
· Drugs.
· Medical Devices.
· Food supplements.
· Cosmetics.
· Home & Office Products.
· Electronics & Home Appliances.
· Fresh fruits.
· Photovoltaic cells.
Health Products and Services
· Sanitary Registrations.
· Import Permits.
· Operating Notices.
· Health Officer.
· Medical Equipment maintenance management.
Electronics & Home Appliances
· NOM Certification: Advice on efficiently obtaining NOM certificates, compliance exemption letters, commercial information, and approvals for import and marketing.
· Certificaciones para equipos electrotécnicos para Estados Unidos, Canadá y Europa.
Quality Management Systems
· Development of documentary support for Quality Management System and preparation for certification of ISO, accreditation ISO/IEC and NOM standards, among others.
· GMP Certification COFEPRIS.
Compliance Training
· Mexico.
· International.
Get In Touch
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