Regulatory Services

Navigating The Path To Regulatory Approval

We aim to achieve the optimum commercial outcome for your product. We understand the challenges you’ll face along the way, your product’s unique requirements, and the particular environment in which your product will be launched.

Our experienced Regulatory team helps you navigate the path to product registration. All our consultants have been recruited from the health technology industry and several have worked in senior positions at the Therapeutic Goods Administration. As we assist you to meet your regulatory requirements and manage your submissions, you can trust our in-depth knowledge of the regulatory process and Australian and international quality standards.

We see your needs and help you with:

• dossier evaluation;
• literature-based submissions;
• rescheduling submissions;
• new drug submissions to the TGA, Medsafe, HSA and other Asian countries;
• submissions for generic and OTC medicines, medical devices (Class I-III) and combination products;
• product information and consumer medical information development;
• regulatory and quality due diligence and gap analysis;
• GMP reviews;
• quality system audits; and
• regulatory portfolio management and compliance service.

For more information on how Commercial Eyes can help you navigate the pathway to regulatory approval, contact Dr Tony Whittaker today.