Do you feel overwhelmed by regulatory affairs? Are you going round and round in circles trying to work out what you need to do? Does the language seem confusing and get you in a spin?
We get it.
It can be tricky to navigate all the necessary requirements. The information to figure it out is publicly available, but it’s not in one spot. It can seem like every new thing you read takes you further away from the finish.
It doesn’t have to be this way.
We draw on our extensive industry experience to make it easy for you to understand and easy to solve.
Making the complex simple
We’re all about making the complex simple and getting you over your regulatory hurdles. We guide you through the terrain and translate complex language into real speak. We even teach you along the way so next time you can do more yourself.
Do you need advice on how to deal with an infringement notice from the TGA? Or do you want help to make sure your idea or product is compliant from the start (which can save you both time and money)?
Although there’s a bit to understand about the regulations, we find most brands get stuck at similar places. We help you to quickly get unstuck so you can focus on what matters. You can focus on making meaningful products that your customers care about. Products that make a positive difference for both your customers and your business.
What do you need help with?
Typical regulatory work we carry out includes:
- Preparation of evidence packages
- Updating indications to permissible indications
- Listing products on the ARTG
- Developing formulations that have ingredients that work and claims that resonate (listed medicines, complementary medicines, foods & cosmetics)
- Generating copy for labels and marketing
- Responding to Section 31 notifications
- Responding to Section 30 notifications
- Development of stability protocols
- Government liaison
- Review of product specifications for accuracy and compliance
- Reviewing ingredients for efficacy and compliance
- Reviewing labels and marketing copy for compliance
Because regulatory affairs is a tricky beast at the best of times, this isn’t an exhaustive list. If we’ve missed something that you’re struggling with, get in touch and we’ll look at a suitable path forward.
Ready to resolve your regulatory affairs concerns?
We’re TGA, food and cosmetics regulatory affairs consultants, ready to help you get unstuck.