Navigating The Path To Regulatory Approval And Compliance
Our experienced Regulatory team helps you navigate the path to product registration and post approval regulatory and quality compliance. All our consultants have been recruited from the health technology industry and several have worked in positions at the Therapeutic Goods Administration.
As we assist you to meet your regulatory requirements, manage your submissions and ensure post approval compliance, you can trust our in-depth knowledge of the regulatory processes and requirements in Australia and New Zealand. Our knowledge is gained from managing, on average, 30 major submissions to the regulatory authorities in both Australia and New Zealand each year.
We see your needs and help you with:
Registered and listed Medicines
- prescription, OTC and complementary medicines
- new chemical entity (NCE) and new biologics submissions
- over-the counter (OTC) and complementary medicines submissions
- generics, biosimilars and non-biological complex generic medicines
- combination product submission to regulatory agencies in Australia, New Zealand, Singapore and other Asian countries;
- literature-based submissions;
- rescheduling submissions;
- Specialty applications including Section 60 appeals, orphan designation, restricted representation and exemption methods.
- NICNAS ingredient assessments
- labelling and claims assessments
Medical DevicesExamples include devices that range from low to high risk, as well as devices that are invasive, active, disinfecting, implantable, software, etc.
- technical file compilation and/or evaluation (including clinical evidence and design examination)
- manufacturer’s evidence applications (including TGA conformity assessment)
- medical device inclusion applications
Regulatory Strategy and General Advice
- regulatory due diligence and gap analysis;
- dossier evaluation;
- competitive intelligence
Regulatory Portfolio Management-Medicines and Devices
- quality systems design and implementation
- quality system audits
- CAPA programs
- vendor assurance programs
- GMP and technical agreement reviews
- product release
- handling and management of product quality complaints
We aim to achieve the optimum commercial outcome for your product. We understand the challenges you’ll face along the way, your product’s unique requirements, and the particular environment in which your product will be launched.