Navigating the path to regulatory approval and compliance
Our expert Regulatory, Quality and Compliance 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, quality and compliance 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, quality and compliance activities. You can trust our in-depth knowledge of the complex regulatory environment in Australia and New Zealand and the various challenges during the approval and life-cycle management process. This knowledge is gained from managing over 150 projects and 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 determinations
provisional determinations
comparable overseas regulator (COR) pathways
rescheduling applications
section 60 appeals
restricted representation and exception methods
portfolio lifecycle management
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
Regulatory publishing strategy and support including:
eCTD and NeeS electronic publishing
creation of eCTD baselines
Disinfectants and sterilants:
ingredient/component and labelling assessments
assessment of claims and instructions for use
TGA liaison and regulatory applications
portfolio lifecycle management
ingredient and labelling assessments
claims assessment
AICIS/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
Maria DionyssopoulosWith her extensive experience in regulatory affairs, Maria Dionyssopoulos will help your business 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.
Quality is important to us
Our processes are supported by our well-established ISO accredited quality management framework to ensure process efficiency and optimal outcomes
