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PRODUCT ASSESSMENT AND CLASSIFICATION
The Health Canada regulatory process can seem like a maze whether your company is a multinational with extensive regulatory experience or a company that is newly emerging in the marketplace. MEDERA helps you navigate this maze by tailoring our strategic regulatory solutions to your needs. MEDERA Consultants has over 15 years of experience in Canadian Regulatory Affairs and obtaining drug approvals for our clients.
Our initial meetings and conversations with clients are used to develop regulatory strategies for a specific project. Our goal is to develop a regulatory strategy that meets both client needs and Canadian regulatory requirements. We then work with the client to implement these strategies.
MEDERA offers a full range of consulting solutions to facilitate Canadian registration of your drug products. MEDERA can handle the entire registration process from submission preparation through to managing the review process with Health Canada. We can also review submissions prepared by your staff to provide a critical review with the goal of identifying deficiencies so that Health Canada's review is more streamlined.
The Food and Drugs Act (FDA) provides the regulatory framework for the registration and sale of drug products in Canada. MEDERA handle all aspects of compliance with the FDA from drug registrations through to drug approvals and then post-approval changes.