MarcM Consulting Canada

Regulatory Affairs Consultants

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Helping clients to generate new business, growth and profits by bridging the regulatory and commercial divides
within and between Latin America, Canada, the United States and the world.
Working with clients globally to manoeuver the increasingly complex regulations presented by
Health Canada, FDA in the United States, health authorities in Latin America such as ANMAT in Argentina, ANVISA in Brazil, INVIMA in Colombia, COFEPRIS in Mexico and DIGEMID in Peru, and other national and regional regulatory bodies and international agencies such as the World Health Organization (WHO) and the Pan-American Health Organization (PAHO).
Offering regulatory guidance built upon extensive industry expertise
with specialization in the highly regulated and constantly evolving industries of pharmaceuticals, medical devices, veterinary medicines, cosmetics, natural health products (NHP) and related over-the-counter (OTC) wares.
Supplying regulatory compliance services in the areas of
product registrations, GMP inspections, ISO conformity, clinical research & trials, bioequivalence studies, DMF preparations,
industry-government relations, in-country and cross-border business negotiations and more.