Regulatory Strategic Guidance - Overview
Generic manufacturers face challenges such as understanding the complexity of Canada’s drug registration guidelines for generic drug approval through an Abbreviated New Drug Submission (ANDS) and complying with the respective guidelines. To overcome them, manufacturers must adopt a robust approach for different types of medicinal products and ensure timely registration and approvals.
Health Canada’s Regulatory strategic guidance involves setting up the right Regulatory roadmap during product development and studies to be performed specific to the dosage form/indication. The submission strategy shall guide the submission timelines, documents/data required for submission, and the approval process.
Without understanding Canada’s drug registration guidelines, manufacturers may face delays in product registration, which can affect costs and go-to-market timelines. Therefore, Freyr provides clients with accurate Health Canada’s Regulatory strategic guidance for registering generic medicinal products under Health Canada’s guidance documents, backed up with Regulatory intelligence reports.
Regulatory Strategic Guidance - Expertise
- Planned submission of generic drug applications as per Canada’s drug registration guidelines.
- Evaluate the latest Health Canada’s Regulatory strategic guidance and provide appropriate support.
- Strategic guidance on day-to-day manufacturing and development activities to design the specification and protocols/reports.
- Guidance in preparation of the pre-submission meeting packages.
- Identification of the possible risks and preparation of risk-mitigation strategies before Health Canada Regulatory submission.
- Regulatory submission strategy for post-approval change submissions.
- Preparation of the response submission strategy for HA queries.
- Regulatory strategy preparation for the expedited review and approval of priority drugs.
- Strategic guidance on planning in the submission of stability and bioequivalence studies.
- Evaluation to determine the legal status of the medicinal product.
