Regulatory Affairs

Having been founded in 1996 as a regulatory affairs consultancy, Novotech has a strong tradition of providing regulatory affairs services to the pharmaceutical and biotechnology industries. In addition to regulatory affairs related to clinical trials which we provide in all the countries in which we operate, we provide the following services in Australia and New Zealand:

• Product development planning services
• Review of CTD dossiers and preparation of marketing applications (prescription, OTC, medical device, complementary medicines, generics and biosimilars)
• Variation submissions
• Literature based submissions
• Presubmission meetings with TGA
• PSUR and drug safety related submissions
• S.31 response management, S.60 and AAT submissions

Novotech is registered with TGA as a sponsor of therapeutic goods, and currently sponsors over 30 products on the Australian Register of Therapeutic Goods (ARTG). This is particularly convenient for our overseas sponsors contemplating submission of marketing authorization applications but without having in place marketing or licencing distribution arrangements yet.