Commercial Eyes: Regulatory and pharmacovigilance services amongst a suite of services offered

16 April 2020

 

Commercial Eyes provides tailored commercialisation advice and a suite of services to pharmaceutical, medical device, diagnostic, biotechnology and health innovation companies.

Over the past 18 years we have worked with more than 500 clients in a complex and changing market environment.

Our clients include companies that currently distribute regulated products in Australia and New Zealand, international organisations exploring how to establish a local enterprise and businesses who market and distribute their therapeutics through a local partner.

Our specialist consultants have sound technical knowledge, substantial practical experience and a pragmatic, solutions-oriented approach that ensures high-quality, client-oriented outcomes.

At Commercial Eyes, we focus our efforts on supporting clients in the regulated therapeutics industry get their products to the patients who need them, when they need them.

We are conscious of the critical role many of our clients are playing and will play in the current environment. Indeed, over the past month we have had many enquiries for direct support in addressing COVID-19 related issues and like many companies across Australia and around the world, our teams have quickly transitioned to working remotely.

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.

Pharmacovigilance

A trusted pharmacovigilance and risk management partner for the pharmaceutical and medical device industry.

Our team has been inspected by the US FDA and TGA on multiple occasions with no critical findings identified.  Our capabilities include coverage of all global and Australian PV regulatory requirements including ICSR management, medical review, signal detection, aggregate reports, RMP and ASA development and the preparation and implementation of Safety Database Exchange agreements.  Our processes are based on a robust Quality Management System, ISO 9001:2015 accreditation and the integration of industry best practice.

Our PV team is highly quality focused, ensuring patient safety throughout a product’s lifecycle from development phases throughout post-marketing surveillance.

Please visit our website for more information, or contact us on +61 3 9251 0777.

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