MarcM Consulting Canada ("MarcM") is a Canadian-based consulting company that provides worldwide regulatory services to pharmaceutical and related industries and that maintains a special interest in bridging and reducing the business divide within the Americas.

As such, -- whether your company is a large, established corporation or a small to medium-sized start-up; whether you require assistance with Health Canada, the U.S. Food and Drug Administration (FDA), any of the Latin American regulatory authorities or other national or regional regulatory agencies; whether you are located in Canada or elsewhere in the world -- MarcM can support all of your regulatory and associated needs.

By drawing upon its extensive experience working directly with regulatory bodies and by collaborating with your company to develop a regulatory strategy that best fits your requirements, MarcM will assist you in achieving time and cost savings in obtaining market approvals for your company's products. The results for you will be speedier product launches and faster returns on investment (ROI).

Furthermore, cross-border and cross-cultural negotiations and communications between your company and its foreign partners may be facilitated and simplified via MarcM's cultural/market-specific knowledge, English/Portuguese/Spanish language expertise, specialized technical advice, overall general guidance and other related services thereby leading to improved synergies and efficiencies between you and your partners.   [TOP]

Specifically, MarcM can:

• Communicate and provide client services in English, Portuguese and/or Spanish.

• Prepare and deliver training and educational programs to businesses, health care organizations and educational facilities. These training programs may cover such subjects as regulatory matters (inclusive of CMC), GMP (inclusive of GLP and validation), GCP, ISO and international harmonization issues.

• Contact, liaise and collaborate with company technical professionals in order to better understand and prepare documentation required for the registration process in each market or country where the company intends to carry out business. How?

• MarcM can assist with the preparation and filing of necessary technical documents (such as target country registration dossiers) so as to facilitate expeditious approvals by the respective health regulatory authorities thereby rapidly improving export prospects in the Americas and elsewhere.

• In conjunction with the document preparation/submission service, MarcM can provide support for the creation, update, review and annotation of product monographs, investigator's brochures, package inserts and product labels.

• As well, MarcM can help with the development and/or revision of product labelling for all related health products in order to meet current government and industry standards.

• If desired, MarcM can also assist with the preparation/filing of (i) quality templates for all pharmaceutical and related products, (ii) Drug Master Files (DMFs) and Site Master Files (SMFs) that comply with current national and international standards and (iii) establishment license applications.   [TOP]

For further details, contact us.

MarcM can also:

• Perform on-site audits to determine if and where facilities and systems may not be constructed and implemented so as to comply with company quality procedures and/or applicable regulations and standards.

• Conduct a gap analysis -- where a Quality Manual and Standard Operating Procedures (SOPs) for your Quality System already exist that are not, or may not be, in full regulatory compliance -- to determine if and how it will be necessary to improve the procedures and/or the related documentation so as to bring them into conformity with regulatory requirements.

• Connect clients with established and experienced clinical research organizations (CROs) in order to reduce lead-times (start quickly) and to lower the cost of clinical studies (achieve savings). Furthermore, MarcM is prepared to coordinate clinical trials as well as bioequivalence/bioavailability studies as a sponsor-supervisor.   [TOP]

For further details, contact us.

As an adjunct to its comprehensive regulatory and quality assurance services, MarcM also offers customized business development services. How?

• With an emphasis on the Americas, MarcM can identify and link up pharmaceutical, cosmetic, distribution and/or related companies that may be interested in partnering or working with your company so as to better promote and sell your company's products and/or services.

• In some countries, signing a contract is not the end of negotiation. A signed contract simply means that the parties have agreed to do business. Serious negotiations often begin after signing. With this reality in mind, MarcM has the necessary experience and expertise to aid in the negotiation of client/partner agreements if so requested.   [TOP]

For further details, contact us.

In summary, MarcM Consulting Canada helps to improve client decision-making and business prospects through a unique continuum of capabilities -- unmatched information, analytics and consulting, a focus on healthcare-related marketplaces and seamless and collaborative partnerships with its clients. From pipeline to market, from every conceivable perspective, MarcM Consulting Canada understands the dynamics of the global regulatory environment and how to help clients to best develop, gain approval for, launch and export products within that complex environment so as to improve countless millions of lives in the Americas and around the world.