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Apart from being the largest home-grown clinical CRO, Novotech also boasts a strong tradition of providing end-to-end regulatory affairs services to the pharmaceutical and medical device industries. The service is designed
to be either project specific "as needed", or as an ongoing "virtual regulatory affairs department" attached to your local or overseas operations for Australia and New Zealand registration or clinical trial needs. Specifically, the following services are offered:
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Prescription / OTC / Generic / Biosimilar / Complementary Medicines - strategic advice, preparation, submission and management of marketing authorisation applications with TGA and Medsafe
CTD dossier reviews - writing and/or reviewing dossier data
Variation submissions
Literature Based submissions
PSUR and drug safety related submissions
TGA Pre-submission meeting
S.31 response management, S.60 and AAT Appeals
Clinical trial regulatory services, including local sponsorship, CTN, CTX, and AQIS permits |
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Additionally, Novotech is registered with TGA as a sponsor of therapeutic goods in Australia and currently sponsors over 30 approved drugs on the Australian Register of Therapeutic Goods (ARTG). This is of particular benefit and convenience to overseas based sponsors contemplating marketing authorization applications in Australia but who have not yet set up local licencing or distribution arrangements. |
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