Commercial Eyes

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Energy Boardroom

Commercial Eyes

Australia

Address: Suite 6, 651 Victoria St Abbotford Victoria,Australia

Tel: +61 3 9428 1899

Web: http://commercialeyes.com.au/

Company description

In 2001, Commercial Eyes’ founder and Managing Director, Andrew Carter, saw an opportunity to use his experience to establish a business that would provide commercialisation services to pharmaceutical and medical device companies.

Starting out with a laptop, mobile phone and a vision for the future, Andrew saw from the outset the value his clients placed on accessing quality, results-oriented services and advice.

From small beginnings Commercial Eyes has rapidly grown to become the leading pharmaceutical and medical device commercialisation company in the Asia Pacific region, with clients from the full spectrum of local and international pharmaceutical and medical device companies.

We have a broad-based team and offices in Sydney, Melbourne and Canberra. Commercial Eyes has provided commercialisation assistance to more than 350 clients and we now have our sights set on the broader Asia-Pacific region.

Products and services

We aim to achieve the optimum commercial outcome for your product. We understand the challenges you’ll face along the way, your product’s unique requirements, and the particular environment in which your product will be launched.

Our experienced Regulatory team helps you navigate the path to product registration and post approval regulatory and quality compliance. All our consultants have been recruited from the health technology industry and several have worked in positions at the Therapeutic Goods Administration. As we assist you to meet your regulatory requirements, manage your submissions and ensure post approval compliance, you can trust our in-depth knowledge of the regulatory processes and requirements in Australia, New Zealand and Asian markets
We see your needs and help you with:
Registered and listed Medicines

prescription, OTC and complementary medicines
new chemical entity (NCE) and new biologics submissions
over-the counter (OTC) and complementary medicines submissions
generics, biosimilars and non-biological complex generic medicines
combination product submission to regulatory agencies in Australia, New Zealand, Singapore and other Asian countries;
literature-based submissions;
rescheduling submissions;
Specialty applications including Section 60 appeals, orphan designation, restricted representation and exemption methods.

Medical Devices

technical file compilation and/or evaluation (including clinical evidence and design examination)
manufacturer’s evidence applications (including TGA conformity assessment)
medical device inclusion applications

Regulatory Strategy and General Advice

regulatory due diligence and gap analysis;
dossier evaluation;
competitive intelligence

Regulatory Portfolio Management-Medicines and Devices
Quality Systems

quality systems design and implementation
quality system audits
CAPA programs
vendor assurance programs
GMP and technical agreement reviews

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