Welcome
•We are a specialized team with more than 10 years of xperience in regulatory advice, survillance of medical devices, recalls, implementation of Quality systems, Holder of Registration in Mexico for manufacturers of medical devices, hospitals, public institutions, laboratories, offices and health professionals.
Our company
Our Purpose
Our purpose is to facilitate the procedures, negotiations and generate business opportunities, between International Companies, Mexican and Latin American Companies in order to meet all requirements, costs, avoiding loss of time for our clients and Introduction to new markets giving growth international projection.
Our Vision
Being a leading partner that supports international trade in products.
This vision guides all our activities, practices and organization to ensure that we add value to our company and our worldwide partners.
Our History
Since our creation almost 10 years ago, we have managed to consolidate the loyalty of our clients thanks to comprehensive and personalized support, creating a valuable bond with our clients.
Our Services
•Counseling in regulatory affairs: Mexican Health Law, NOMs(Mexican Official Rules)(labeling, Survillance, GMP), quality systems, good storage practices.
•Advice on foreign trade
•To comply Latin America´s regulatory and Foreign trade procedures.
•Specialized translation, technical or clinic.
•Proceedings with Secretary of Health, Cofep
•Counseling in regulatory affairs: Mexican Health Law, NOMs(Mexican Official Rules)(labeling, Survillance, GMP), quality systems, good storage practices.
•Advice on foreign trade
•To comply Latin America´s regulatory and Foreign trade procedures.
•Specialized translation, technical or clinic.
•Proceedings with Secretary of Health, Cofepris:
•Health records (RS) of Medical Devices (IA, I, II, III): Ordinaries and equivalence agreements.
•Health registrations of food supplements, medicines
•Surveillance – Techno vigilance , pharmacovigilance
•Sanitary import permits
•Permits for import &export goods.
•Advertising Permissions
•Warehouse of medical devices and pharmaceutical industry
•Proceedings with Ministry of Treasure, Customs:
•Inscriptions to the Imports & export registration
•Customs clearance
•International logistic
•Import & export goods
•Specialized translation:
•Language English, French, German, Italian to Spanish