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 Australian Register of Therapeutic Goods (ARTG).
Experience in handling the MAA submission for Pharmaceutical Products to TGA will be critical for successful submission and approvals. Expertise in providing the typical requirements of TGA in the Marketing Authorization Application is very important for smooth review/approval process of application. Inadequate data leads to delay in approval and subsequently delay in market-entry.
Freyr, as a proven Regulatory partner, assists pharmaceutical manufacturers/MAA holders to manage the legal, administrative requirements along with communications with the TGA. Freyr provides registration support, which allows the MAA holders/manufacturers access the Australian market with the registration and distribution of their pharmaceutical products.
With in-depth understanding on the TGA requirements/practices and experience in handling multiple MAA applications for the TGA, Freyr can provide following services to 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 Bio-equivalence 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 eCTD format
- Handling the TGA queries with strategies and preparation of response package for submission of Marketing Authorization Approval