Regulatory Affairs

A digital infographic with hexagonal icons related to pharmaceutical and medical device development, regulation, and compliance, including images of test tubes, DNA strands, and scientific research.

Our Regulatory consultants have the industry experience and knowledge you can rely on to provide accurate advice and guidance for your project.

Strategic Advice and Guidance

  • Navigate regulatory requirements (legislation, guidelines, standards) to clarify available options and streamlined pathways to regulatory approvals.

Prepare Regulatory Submissions

  • Technical documentation packages to support approval and post-approval activities for medicines (prescription, over-the-counter, complementary) and medical devices/diagnostics.

  • Clinical trial submissions (notifications/approvals) for unapproved therapeutic goods.

Labelling, Artwork and Advertising Code Compliance

  • Review proposed labelling and artwork against legal requirements.

  • Advise on compliance of promotional material with Advertising Code.

Regulatory Agency Interactions

  • Direct communication with Regulatory Agencies.

  • Clarify and resolve requests for information related to applications.

Permits

  • Obtain approvals for other required permits, e.g., Office of Drug Control, import/export permits.