Navigating The Path To Regulatory Approval And Compliance
Our expert Regulatory Services team helps you navigate the path to successful product registration and compliant lifecycle management. All our consultants are highly experienced with an in-depth knowledge of regulatory and quality processes and requirements in Australia and New Zealand. We specialise in prescription, over the counter (OTC) and complementary medicines, sunscreens, medical devices and cosmetics. Our team also includes electronic publishing experts who are adept at using a range of software solutions.
We will assist you to develop effective submission strategies, meet your regulatory requirements, manage your submissions and enhance your regulatory and quality compliance. You can trust our in-depth knowledge of the complex regulatory environment in Australia and New Zealand and the various challenges during the approval process. This knowledge is gained from managing, on average, 30 major submissions to regulatory authorities annually.
We understand your needs and help you with:
Regulatory strategy development:
- regulatory due diligence and gap analysis
- dossier evaluation
- competitive intelligence
- presubmission meetings
- resubmission strategies
- bioequivalence and clinical strategies
Prescription, OTC and complementary medicines
Submissions for:
- new chemical entities
- new biological medicines
- generics, biosimilars and non-biological complex generic medicines
- OTC, complementary medicines, and sunscreens
- fixed dose combination products
Specialty applications including:
- literature-based submissions
- orphan drug designations
- priority review
- provisional approval
- comparable overseas regulator (COR) pathways
Portfolio life-cycle management
Regulatory publishing strategy and support including:
- eCTD and NeeS electronic publishing
- creation of eCTD baselines
Medical Devices (including IVDs and software)
- technical file evaluation and compilation
- clinical evidence and design examination
- manufacturer’s evidence
- TGA conformity assessment
- ARTG inclusion applications
- portfolio lifecycle management
- ingredient and labelling assessments
- claims assessment
- NICNAS/FSANZ/government liaison
- portfolio lifecycle management
- GMP and technical agreement reviews
- batch release recommendations
- complaint handling
- medicines shortage notifications
- product quality reviews
Recall management, communication and support
We aim to achieve the optimum commercial outcome for your product. We understand the environment in which your product will be marketed so are well positioned to enhance your regulatory and quality compliance obligations.
