List of Contract Manufacturing Companies in Australia - 5

Anatomics is a medical technology company that has been manufacturing high-quality medical devices, prosthetics and software solutions since 1995. Based in Melbourne Australia, Anatomics manufactures high quality patient specific implants for global distribution and in-licenses novel technology for Australian and New Zealand distribution. We strive to be recognised as a trusted and innovative provider of quality surgical products. Our mission is to work in partnership with healthcare professionals and medical device companies to provide the highest quality surgical products. We are a company of experienced and dedicated team members who strive for better surgical outcomes by initiating internal product developments and searching the world for the latest innovations in technology to make surgical procedures more effective for our partners and more comfortable for their patients.

Cell Therapies Pty Ltd is a contract development and manufacturing organization (CDMO) that manufactures and deploys advanced cell-based therapies to the global market. Established in 2003, Cell Therapies is one of the most experienced GMP compliant manufacturers of cell therapies, gene therapies, cellular immunotherapies, and regenerative medicine products globally. We have a 13-cleanroom GMP facility that meets global regulatory and international organisation for standardisation (ISO) standards benchmarked by the Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S). Our services cover the complete manufacturing process from development to deployment, providing needle-to-needle control with clinical integration. Our facility is co-located with the Peter MacCallum Cancer Centre in Melbourne, Australia, providing access to hospitals, research institutes, and universities to support product development, translation to the clinic, and patient access. Please contact us through our website to discuss potential collaborations.

Formulytica is a specialty contract research, development and manufacturing organisation (CRDMO) with extensive expertise in formulation, analytical method development, and manufacture for a wide variety of topical and injectable dermatology, pharmaceutical, cosmetic and agricultural products. The laboratory is attached to a FDA, TGA and APVMA registered manufacturing plant that allow us to deliver unmatched product development and chemistry, manufacture and control (CMC) services including clinical and stability registration batch preparation. Formulytica is staffed with research scientists with an average 20 years' experience in the pharmaceutical industry, each now making their skills and experience available to other companies to develop or register new products.

Founded in 1975, IDT Australia is a publicly listed Australian pharmaceutical manufacturing company, based in Boronia Victoria. Our experienced and awarded team of scientists and specialists provide a flexible and comprehensive service, focussed in our three strategic pillars: Active Pharmaceutical Ingredient synthesis design, scale up and cGMP manufacture including high potent molecules Specialty Orals novel and early stage design, formulation and cGMP manufacturing specifically targeting neuro disorders Advanced Technology, complex formulations for novel injectable drug development through to cGMP manufacture. This pillar includes RNA and Antibody Drug Conjugates. IDT Australia also has a fully equipped laboratory approved to TGA and FDA standards to develop, validate and operate GLP analytics for release, process validation and stability. IDT Australia has labelling and packaging capacity and capability and specialises in clinical trial labelling and packing.

About Vestech Medical Device innovation and commercialisation is fraught with risk, missteps and wastage. Navigating the successful passage of a device from invention to commercial success is Vestech's area of expertise. Understanding the landscape, working with innovators and providing collaborative advice are key components of our day to day activities. Experience & Process When it comes to Medical Device development and commercialisation, nothing beats experience. Vestech has that hands on experience and more. Vestech and its team have been in the field of medical device commercialisation for more than 30 years. During that time Vestech has accumulated direct and personal experience in the following areas: The technical aspects of device design The regulatory requirements Intellectual property protection Liaising with tertiary institutions Business planning Reimbursement strategies Export development International regulations and systems Capital raising Listed entities management Legal requirements Human resource development Industry organisation engagement Federal and state policy development and lobbying Project management Exit strategies During the realisation of a medical device project, Vestech works with Australia's top specialist vendors and consultants to assure a first class result. Vestech's connections within Australia and Internationally have been built up and tested over decades to ensure "no surprises" delivery.