Vanguard Biopharm LLC, a leading expert in the international regulation of medical devices and cosmetics.

Our company facilitates the sale of medical devices, pharmaceuticals, and cosmetics between countries with differing regulations.

USA-EUROPE

LATAM-EUROPE

ASIA-EUROPE

Compliance & Regulatory Services

We are experts in the regulatory affairs of medical devices, cosmetics, human tissues, pharmaceuticals, and their logistical processes.

Cosmetics and makeup:

We set up quality systems for the manufacturing and import of cosmetics and makeup according to European and Latin American regulations. We advise on international logistics for exporting and importing these products. We can act as regulatory representatives for cosmetics in the North American market for manufacturers outside the USA and also have agreements in Europe to provide regulatory representation for manufacturers outside the European Union.

Other sectors:

Pharmaceutical broker:  We facilitate the international buying and selling of medications by acting as intermediaries between manufacturers, wholesalers, and distributors. We help manage transactions and ensure regulatory compliance.

Human tissues:  We implement quality systems under European health regulations for the storage and distribution of human tissue banks across various European countries. We also provide advice on exporting human tissues from manufacturers in the USA to Europe.

Medical Devices and In vitro diagnostic products (IVD):

We implement quality systems for the manufacturing, importation, and distribution of medical devices under European regulations and those of various Latin American countries. We provide advice on logistical processes for the export/import of these goods from the USA and Asia (China and South Korea). Thanks to our agreements in Europe, we can offer manufacturers regulatory representation services in Europe (EC REP).

Primary projects and focus areas by country

If the activity or service is not available in the requested country, or if your country is not listed, please contact us.

European regulatory framework

Representamos sus intereses en el ámbito de la regulación sanitaria para empresas incorporadas en cualquier jurisdicción internacional que quieran introducirse en la complejisima burocracia europea . Contamos con Partners en Europa especializados que le pueden proveer:

EC REP / Persona responsable en cosméticos/ Logistica

We represent your interests in healthcare regulation for companies incorporated in any international jurisdiction seeking to navigate the highly complex European bureaucracy. We collaborate with specialized partners in Europe who can provide you with:

EC REP/Responsible Person for Cosmetics/Logistics

U.S. regulatory framework

Servicio de US Agent para la FDA, un requisito obligatorio para empresas extranjeras que comercializan cosméticos y dispositivos médicos en EE.UU.

Actuamos como su representante oficial ante la FDA, gestionando comunicaciones, notificaciones regulatorias e inspecciones. Además, brindamos apoyo en registro de establecimientos y productos, cumplimiento normativo (MoCRA, 510(k), QSR) y estrategias para la entrada al mercado estadounidense.

US Agent service for the FDA, a mandatory requirement for foreign companies marketing cosmetics and medical devices in the U.S. We act as your official representative before the FDA, managing communications, regulatory notifications, and inspections. Additionally, we provide support in establishment and product registration, regulatory compliance (MoCRA, 510(k), QSR), and strategies for entering the U.S. market.

Regulatory framework in Latin America

Ofrecemos servicios regulatorios en los principales mercados de Hispanoamérica, asegurando el cumplimiento normativo para la comercialización de dispositivos médicos ( insumos), cosméticos así como broker de medicamentos.

Trabajamos con las agencias sanitarias más exigentes del continente: COFEPRIS (México), ANMAT (Argentina), INVIMA (Colombia), ISP (Chile), DIGEMID (Perú) y DIGEMAPS (República Dominicana), facilitando registros sanitarios, cumplimiento de Buenas Prácticas de Manufactura (GMP/BPM) y estrategias de entrada al mercado.

We offer regulatory services in the leading markets of Latin America, ensuring compliance for the commercialization of medical devices (supplies), cosmetics, and pharmaceutical brokerage.

We work with the region’s most demanding health agencies: COFEPRIS (Mexico), ANMAT (Argentina), INVIMA(Colombia), ISP (Chile), DIGEMID (Peru), and DIGEMAPS (Dominican Republic), facilitating sanitary registrations, compliance with Good Manufacturing Practices (GMP/BPM), and market entry strategies.

Empresas del sector farmacéutico confían en nuestra experiencia para cumplir con las normativas de COFEPRIS, ANMAT, INVIMA, ISP, DIGEMID y DIGEMAPS, AEMPS, FDA, asegurando su acceso a los mercados más exigentes.

Pharmaceutical companies trust our expertise to comply with the regulations of COFEPRIS, ANMAT, INVIMA, ISP, DIGEMID, DIGEMAPS, AEMPS, and the FDA, ensuring their access to the most demanding markets.