Drug Regulatory Submissions
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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. DSA helps you navigate this maze by tailoring our strategic regulatory solutions to your needs. DSA Consultants has over 20 years of experience in Canadian Regulatory Affairs consulting and obtaining drug approvals for our clients. 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. DSA Consultants offer a full range of consulting solutions to facilitate Canadian registration of your drug products. A DSA Regulatory Affairs Consultant 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. DSA Consultants handle all aspects of compliance with the FDA from drug registrations through to drug approvals and then post-approval changes. We prepare for filing to the:
We prepare a full range of drug regulatory submissions for product licensing in Canada:
Contact us to find out more about our drug regulatory consulting services or to receive a free copy of our white paper on marketing a healthcare product in Canada, click here. Drug Labelling ReviewDSA Regulatory Consultants can also handle the associated review of product labels to ensure compliance with Canadian labelling regulations as found in the Food and Drugs Act (FDA). All labelling materials must be compliant with Canadian Regulations and the marketing authorization for the product including:
Our Canadian Regulatory services include pre-approval label reviews or label development to guide, and advise you on changes to labelling which will help maximize claims and/or expedite product approvals. DSA also offers post-approval label reviews to ensure compliance with the marketing authorization or to help identify where supplemental filings to Health Canada may be required. Precursor Class A&B SubmissionsThe Precursor Regulations were approved in 2002. These regulations provide a framework for monitoring and controlling precursors and other chemicals frequently used in the production of illicit drugs. There are two classes of precursors. Class A precursors are essential components of illicit substances. Class B precursors are mostly solvents and reagents that are often used in illicit manufacturing processes. Many of the noted precursors do have legitimate uses in many pharmaceuticals and cosmetics. The goal of these regulations is to enable Health Canada to control precursors, while at the same time be responsive to the legal uses of these chemicals. If any of your currently manufactured products are formulated with either Class A or Class B precursors, we can help you determine if your products qualify for an exemption. If your products do not qualify for an exemption, we will help you obtain the required licenses and permits. Provincial Formulary ListingsSecuring a formulary listing is crucial to the success of a new drug product. DSA has the expertise to prepare your submissions to the provincial drug plans and private payer plans. We prepare detailed CDR (Common Drug Review) Submissions to help you secure plan listings and ensure patient access to your drugs. Domestic Substances ListPursuant to the New Substances Notification Regulations (NSNR), the Domestic Substances List provides an exhaustive listing of substances which are known to be in commerce for the manufacture of products regulated under the Food and Drugs Act (FDA). Products not on the DSL list are therefore subject to the NSNR. A submission is prepared to Health Canada and Environment Canada who jointly determine, based on our submission, whether the manufacturing or importing of the substance poses any risk to the health of Canadians or the environment. DSA can prepare your DSL submissions to help you gain approval for materials to be imported and used in manufacture. Adverse Drug Reaction Reporting and PSURsDSA Consultants can help you develop programs and procedures for Adverse Event Reporting/Adverse Drug Reaction Reporting and preparation of Product Safety Update Reports (PSUR). We can assist you with investigations for adverse drug reactions (ADRs) to determine if events are reportable. We can help you compile your PSUR or review prior to filing. Regulatory Submission Compliance AuditsIs your firm in compliance with the terms of your NoC (Notice of Compliance) and the commitments made during your submission review or marketing authorization? Is your regulatory filing current and up-to-date? With the revocation of “sufficient time”, many companies are finding that their regulatory filings have not been maintained and are looking for regulatory submission audits to assess the need for subsequent filings with Health Canada or other regulatory authorities. DSA handles all types of submission audits to assess compliance with both the market authorization and current regulation. Contact us to find out more about our drug regulatory consulting services or to receive a free copy of our white paper on marketing a healthcare product in Canada, click here. |
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