After an agonising wait during an evaluation, you receive communication from the APVMA that one or more aspects of your application has not met the criteria for the APVMA to support registration. The wording can be intimidating, and generally if you do not wish to accept their option, the APVMA are required to issue an 8S notice, proposing to refuse the application. I can tell you from experience, an 8S letter is not the kiss of death for your application that you think it is. Rather it’s the opportunity your organisation needs to address the issue that prevents the APVMA being satisfied that your product has met the relevant statutory criteria. At this point, having an expert in your corner may just add the steely resolve that’s required to get the application over the line.
A successful response in this time-critical situation requires getting up to speed on the issue quickly so that we can apply or unique skills and expertise to build your case. We have a successful track record of resolving these to the satisfaction of our clients. We are experienced operators, responsive and motivated to get you a successful outcome.
If you find yourself in this situation, talk to us.