Understanding the complexity of registration requirements for a generic drug through an Abbreviated New Drug Submission (ANDS) and complying with the respective guidelines are the challenges that generic manufacturers face in identifying an appropriate Regulatory submission strategy for Canada. To overcome these challenges, manufacturers must adopt a robust approach for different types of medicinal products to ensure efficient and timely drug product registration and approvals.
A submission strategy involves setting up the right Regulatory road map with various milestones during product development and also studies to be performed specific to dosage form/indication. The submission strategy shall provide guidance on submission timelines, documents/data required for submission, approval process.
Without an understanding of appropriate Regulatory strategies and their implementation, manufacturers may face delays in product registration which in turn can affect costs and go to market timelines. Therefore, Freyr provides clients with accurate Regulatory submission strategies for registering generic medicinal products in accordance with Health Canada guidance documents, backed up with Regulatory intelligence reports.
Submission planning of generic drug applications through the appropriate Regulatory pathway as per Health Canada submission guidelines
Evaluate the latest Health Canada submission guidelines and provide appropriate guidance
Strategic guidance on day-to-day manufacturing and development activities to design the specification and protocols/reports
Guidance in preparation of pre-submission meeting packages
Identification of possible risks and preparation of risk-mitigation strategies before submission of ANDS to Health Canada
Regulatory submission Strategy for post-approval change submissions
Preparation of response submission strategy for HA queries
Regulatory strategy preparation for 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