Therapeutic Goods Administration (TGA), the Health Authority for Australia, has very specific requirements with different registration categories for various types of pharmaceutical products for the registration and entry into the Australian Register of Therapeutic Goods (ARTG).
Experience in handling the Marketing Authorization Application (MAA) submission for pharmaceutical products to TGA is critical for successful submission and approvals. Expertise in meeting the typical requirements of TGA in the MAA is very important for smooth review/approval process of the application. Inadequate data leads to a delay in approval and subsequently, a delay in the market entry.
Freyr, as a proven Regulatory partner, assists pharmaceutical manufacturers/MAA holders to manage the legal and administrative requirements along with communications with the TGA. Freyr provides registration support which allows the MAA holders/manufacturers to access the Australia market with the registration and distribution of their pharmaceutical products.
With an in-depth understanding on the TGA requirements/practices and experience in handling multiple MAA applications for the TGA, Freyr can provide the following services to the MAA holders:
- Guidance on Regulatory submission road map to identify the application category type.
- To act as legal office and contact point in Australia.
- Manage the communications with the TGA for registration and follow-up for approvals.
- Support in interaction with the TGA on scientific aspects.
- Guidance in selection of Test Product and Reference Medicinal Product bio-batch lot for bioequivalence study.
- To provide support in selection of dissolution parameters/multimedia for performance of dissolution for test product and Reference Medicinal Product (RMP).
- Support in the preparation of Product Development Report (discriminatory nature of media).
- Finalization of the specifications for finished products, in-process/intermediates and review of protocols/reports for exhibit batches/stability study.
- Technical gap-analysis of source documents/data for adequacy against the TGA specific requirements.
- Compilation, technical review, finalization, publishing, and MAA submission in the eCTD format.
- Handling TGA queries with strategies and preparation of response packages for submission of Marketing Authorization Approval.