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The international regulatory affairs consultants at MarcM Consulting Canada ("MarcM") have over twenty-five years of accrued knowledge and industry expertise in Latin America, the United States, Canada and elsewhere. Specializing in pharmaceutical, medical device and related industries, MarcM's team is uniquely positioned to leverage its experience with Latin American markets and its multiple language skills (English, Portuguese and Spanish) to provide exceptional service, indispensable technical guidance and overall value in pharmaceutical consulting to its clients.

In early 2008, David Emerson, Canada's then-International Trade Minister, was quoted as saying that "We have to open our doors to trade, investment, knowledge, science and technology. As countries around the world do the same, including our partners and friends in Latin America and the Caribbean, the opportunities to do business and create a better life for our people will multiply infinitely."

The REGULATORY AFFAIRS CONSULTANTS at MarcM Consulting Canada focus principally, but not exclusively, on ™ Bringing the Americas Closer Together

In contrast, challenges presented by import tariffs, tax and regulatory systems, labour markets and infrastructure sometimes confront foreign companies looking to do business elsewhere. It is in these areas, throughout the Americas and globally, that MarcM can assist with gathering market intelligence, developing local contacts, surmounting language barriers and manoeuvering mazes of regulatory restrictions. And by analyzing the strengths and weaknesses of client companies and their local and global competitors, MarcM can help businesses to meet the needs of the various markets within North and South America, and internationally.

Furthermore, since product registration (inclusive of GMP inspections, clinical research/trials, bioequivalence/bioavailability studies and DMF/CTD preparations) is frequently a major constraint on export sales because of its complexity, expense and time-consuming nature, MarcM can save time and money for its clients via proper preparation of the necessary technical documents. With the help of MarcM's regulatory guidance, submissions for pharmaceuticals, drugs, medical devices, natural health products, cosmetics and many other goods can be expedited.

The result for clients is a rapid improvement in export opportunities, concomitant market capitalization and cost savings.

We offer the following services to help clients achieve full regulatory compliance, for example:
  • assistance with the preparation and filing of technical documents such as registration dossiers;

  • support for the creation, update, review and annotation of product monographs, investigator's brochures, package inserts and product labels;

  • assistance with the preparation and filing of quality templates, Drug Master Files (DMF), Site Master Files (SMF) and establishment license applications;

  • preparation and delivery of regulatory and GMP training programs;

  • performance of on-site facility and systems audits as well as subsequent gap analyses; plus

  • much more.

By working hand-in-hand with our clients, we help to attain market approvals more quickly thereby leading to speedier product launches and more rapid returns on investment.
[Additional detail and further explanation can be found on our Services webpage.]

Although the size of the North American pharmaceutical market is large in comparison to that of the balance of the western hemisphere, the rate of growth in sales of prescription drugs, medicines, medical devices, non-prescription health products, and related commodities has as of late often been significantly greater in Latin America. Moreover, this rapid growth in combination with the availability of wider competitive opportunities in Latin America creates commercial potential in the south of the Americas that in many respects rivals that of the hemispheric north. Brazil, for example, with an economy ranked in the top ten globally -- second overall in the western hemisphere -- and with its mature industries and recent economic expansion, annually conducts billions of dollars in trade with Canada. In 2011, Canadian exports to Brazil totalled $2.8 billion whereas imports from Brazil were even greater at $3.9 billion. During the last several years, Brazil also became Canada's 8th largest foreign investor with the latter attaining 11th position in Brazil. Thus, without having to scour more distant locales around the globe, client companies from Argentina in the south to Canada in the north can use MarcM's regulatory compliance and business development services to take full advantage of the huge scope for entrepreneurial expansion within the Americas.

In summary, given the numerous cultural differences, diverse regulatory agencies & procedures, myriad of medical and pharmaceutical practices & standards and often critical process timelines of regional markets the world over, success in frequently hard-to-access markets is grounded in the cultural relationships, experience and knowledge of a regulatory team with an accomplished local track record.

MarcM Consulting Canada, working with you as your regulatory partner, can and will provide exceptional, personalized and expert service as an integral component in building and protecting your company's brand and profits throughout the Americas and globally.


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