Regulatory Affairs

  • Regulatory Strategy and Planning

    Vanguard Clinical offers strategic guidance in navigating regulatory pathways and requirements for clinical trial approval. We develop customized regulatory strategies aligned with client objectives and regulatory guidelines to ensure timely approvals and compliance. Vanguard Clinical empowers clients and stakeholders with the knowledge and skills needed to mitigate and avoid potential risks to timelines based on current/changing regulatory landscapes.

  • Regulatory Submissions Management

    Our experienced team manages the preparation, compilation, and submission of regulatory documents to health authorities, including Investigational New Drug (IND) applications, Investigational Device Exemptions (IDEs), and Marketing Authorization Applications (MAAs).

  • Labeling and Packaging Compliance

    We provide expertise in labeling and packaging compliance, including product labeling design, review, and approval to meet regulatory requirements. Our meticulous approach ensures accuracy, consistency, and compliance with labeling regulations across target markets.

  • Post-Market Regulatory Support

    Vanguard Clinical offers comprehensive support for post-market regulatory activities, including adverse event reporting, periodic safety updates, and regulatory compliance monitoring. We help clients navigate post-market requirements and maintain product compliance throughout the product lifecycle.