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When providing MAH local representation, are ongoing compliance reporting fees included in the retainer or charged as additional services?

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About Freyr Australia

Freyr Australia is a regulatory consultancy that supports Life Sciences companies with product registration and related activities in Australia. Its services include interactions with the Therapeutic Goods Administration (TGA) and AICIS, new product applications, MAH/local representation, TGA manufacturing site registration, market entry strategy, and acting as QPPV. The firm also offers pharmaceutical lifecycle management support, query support management through to approval, and ad-hoc regulatory affairs consultation. It provides tailored support for TGA eCTD submissions and helps companies navigate local regulatory requirements. Freyr describes itself as part of a global organization operating in more than 120 countries with ISO 9001 and ISO 27001 certifications.

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Sydney, NSW, 2000, AU