Regulatory Strategic Guidance

Overview

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.