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.

Freyr Expertise

  • 01

    Submission planning of generic drug applications through the appropriate Regulatory pathway as per Health Canada submission guidelines

  • 02

    Evaluate the latest Health Canada submission guidelines and provide appropriate guidance

  • 03

    Strategic guidance on day-to-day manufacturing and development activities to design the specification and protocols/reports

  • 04

    Guidance in preparation of pre-submission meeting packages

  • 05

    Identification of possible risks and preparation of risk-mitigation strategies before submission of ANDS to Health Canada

  • 06

    Regulatory submission Strategy for post-approval change submissions

  • 07

    Preparation of response submission strategy for HA queries

  • 08

    Regulatory strategy preparation for expedited review and approval of priority drugs

  • 09

    Strategic guidance on planning in the submission of stability and bioequivalence studies

  • 10

    Evaluation to determine the legal status of the medicinal product

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