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Regulatory, Quality & Compliance

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

Cosmetic and food products:

ingredient and labelling assessments

claims assessment

AICIS/FSANZ/government liaison

portfolio lifecycle management

Quality systems:

GMP and technical agreement reviews

batch release recommendations

complaint handling

medicines shortage notifications

product quality reviews

recall management, communication and support

Maria Dionyssopoulos

Maria Dionyssopoulos

With 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

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