Yes, throughout my career I have been involved with over 100 products that have been registered by the APVMA or New Zealand’s ACVM. These ranged from a typical ‘generic’ style to novel therapeutic products. My specialty is taking a therapeutic product desired by a client, and adding additional value. This may be by modifying the formulation to improve absorption, prolong efficacy, add target species, extend claims, or just cheaper to manufacture.
Product registration in Australia is challenging. We have a first-world regulatory system mandated by the Australian people through the government of the day. We have a very well educated consumer base who are increasingly aware of the impact chemicals have on humans, animals and the environment. Add a rapid mechanism of broadcasting customer displeasure through social media and this creates a ‘risk aversion’ paradigm within our regulator.
The Pia Pharma Regulatory Affairs team take this head on. We understand the APVMA process and requirement to address the various statutory criteria. We use well planned and executed scientific studies to generate the required data. We use existing science and literature to support our scientific arguments and present a case that leads the evaluator to the desired conclusion. It is tried and tested…it works.