Gain clear guidance on all aspects of Regulatory Affairs, Quality Assurance, Strategic and Technical Advice for new and existing products within Australia and New Zealand.
Local and international companies in the pharmaceutical, biotechnology and medical device sectors work with us to navigate the different regulatory requirements for the region so to achieve rapid regulatory approval and market entry.
Work with our personnel who have extensive industry experience with all classification of medicines, medical devices and complementary medicine registrations and compliance.
If you have a short term project or long term collaboration, they will advise and deliver to your requirements.
"Thank you very much for your help in getting my products organised from a compliance perspective in New Zealand. Without your assistance and guidance (and Patience) it would have been a much more stressful and time-consuming affair for us. Appreciate your time to break everything into plain English for me"
How we can support you
Clinical Trial Approvals - Medsafe (NZ) and TGA (AU)
- Application preparation and submission through to approval
- Act as your local country clinical trial Sponsor
- Ongoing reporting responsibilities
- Importation requirements
- Labeling review
- Quality review
Commercial Product Support
New medicines application and product life-cycle management - Medsafe (NZ) and TGA (AU)
- Gap analysis of submission dossier
- Consolidation of submission package according to Medsafe or TGA requirements
- Review of labeling
- Across different categories of products - pharmaceuticals, biotech, medical device and natural health products.