Our Services
Regulatory support for the stage you are at.
Whether you are considering a new product, adapting an overseas product for Australia or working through a specific compliance requirement, RegPartners provides clear advice and practical project support.
Choose your starting point
You can start with a focussed session, engage RegPartners for a defined review, request a tailored project scope or arrange ongoing support. Choose the option that best reflects the type of help you need now.
Free 15-min Discovery Call
Not sure where to start? Let's talk.
You know you may need regulatory support but are not sure which service fits your product, stage or situation. This short introductory call is an opportunity to briefly explain what you are working on and the help you are looking for.
We will identify whether RegPartners is a suitable fit and discuss the most appropriate next step. The call does not include product-specific regulatory advice or document review.
Regulatory Pathway & Strategy
A clearer pathway before you invest further.
You are formulating a new complementary medicine or bringing an existing overseas product to Australia and want to understand whether the listed medicine pathway is feasible before investing further.
We consider your proposed ingredients and intended claims at a high level, discuss the key requirements with you in a live session and provide a practical compliance checklist. You will leave with a clearer understanding of the pathway, potential issues and what to do next.
Done-for-you Services
Practical help to get the regulatory work done.
You have moved beyond initial questions and need a specific regulatory task completed. This may include a formulation and ingredient review, evidence package, GMP clearance support, label review, AUST L listing submission or advertising review.
RegPartners will confirm the scope, information required and expected output before work begins. You will receive practical written feedback or a completed regulatory deliverable to help move your product or compliance activity forward.
On-going Regulatory Support
Your own regulatory department, when you need it.
You are a founder or a small team looking for ongoing regulatory support, or an established business needing an extra pair of hands when things get busy.
We can assist with regulatory advice, strategy and hands-on work, helping you plan for your next steps and complete the tasks need to keep your products and projects moving.
Book a call to discuss the support you need and pricing options to suit your business.
Done-for-you Services
When you need more than advice, RegPartners can complete defined regulatory reviews and submission activities to help move your product forward. Engage us for one specific service or combine related activities into a tailored project.
For international brands, these services can also be scoped together as part of an Australian market-entry project.
Formulation & Ingredients
Check your formulation against applicable listed medicine ingredient requirements before progressing with claims, labels or listing.
Claims & Evidence
Assess whether the available evidence supports your proposed indications in the context of your ingredients and finished product.
GMP Clearance Support
Assess and prepare for the TGA GMP clearance process when using an overseas manufacturer.
Label Compliance Review
Check your product label against applicable Australian listed medicine requirements before artwork is finalised, printed or launched.
AUST L Listing Submission
Prepare and submit your AUST L listing once the formulation, claims, evidence, manufacturer and product information are ready.
Advertising Review
Check agreed website, social media, email, brochure or other promotional material against Australian therapeutic goods advertising requirements.
