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Regulatory Services

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


Cosmetic and food products

ingredient and labelling assessments

claims assessment

NICNAS/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

With her extensive experience in regulatory affairs, Maria Dionyssopoulos (Associate Director, Regulatory Services) 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.

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