Radpharm Scientific

Radpharm Scientific has enjoyed two decades as a dependable, leading manufacturer of quality radiopharmaceuticals. In addition to this, we offer exemplary Contract Manufacturing Services, proven over many years of clinical and commercial production. Our new Contract Laboratory Analysis facilities complete the picture and demonstrate our growing capacity in aligning partnerships with Biotechnology and Pharmaceutical Development.
Our quality team includes expertise in radiopharmaceutical chemistry and medical technology.

Skilled specialists in quality assurance, pharmacology, and production are integrated with professionals in global and regional Regulatory frameworks.
Radpharm Scientific’s comprehensive capabilities can meet your pharmaceutical needs, from pre-clinical development to registration; from Active Pharmaceutical Ingredient to Final Product.

Radpharm Scientific, a Division of Global Medical Solutions Australia Pty Ltd, holds cGMP certification from the Australian Therapeutic Goods Administration (TGA) for Manufacture of Therapeutic Goods. TGA certification is recognised by all ICH countries including EMEA in UK and Europe, and the FDA in USA.

We have four core business components:

• Manufacture and supply of Tc99m radiopharmaceutical ‘cold kits’
• GMP Contract Manufacture business: in partnership with biotechnology, pharmaceutical industry & veterinary.
• GLP Contract Laboratory Chemical Analysis
• Drug development and GMP lyophilisation and fill and finish manufacture

Our vision:

• Provision of superior quality products and services, in a timely and efficient manner
• Utilising a collaborative approach to meet and exceed customer satisfaction in Australasia
• Continued commitment to excellence, providing innovative and exceptional products and services through continuous enhancement of people, procedures & processes
• Development of new products for the Global Medical Solutions domestic and international business
• Maintain distinction as a manufacturer of both lyophilised and liquid injectable pharmaceuticals, focussing on high quality product for both individual patient, and sponsor satisfaction. Whether a project is large or small, pre-clinical, clinical, or commercial we can meet your needs.
• Using validated services and products, to supply the right result and assist our clients in realising their goals in drug development.
• To maintain premier standards in dossier development and good regulatory practices

We also seek to preserve our position as a leading Australian supplier of radiopharmaceuticals

Radpharm Scientific, for capabilities to meet your needs, and outcomes to surpass your expectations

Regulatory Services

• GMP Regulatory compliance to TGA, FDA, and EU standards
• GMP licensed by the TGA for Manufacture of Therapeutic Goods
• Compilation of dossiers in Common Technical Document (CTD) format
• Category 1-3 drug applications

From Development to Manufacture and Manufacture to Registration

• Pre-clinical and clinical drug product development for biotechnology, pharma & veterinary
• Laboratory level formulation development
• Pilot batches for process and analysis validation
• Lyophilisation
• Sterile product manufacturing capabilities
• Sterile fill and finish vials, aseptic filling
• Gamma, steam, and dry heat sterilisation
• GLP analytical laboratory services
• Quality assurance & validation, BP / Eu.Ph / USP compliant quality control systems
• Pharmaceutical batch production (from raw materials to released product)
• Radiopharmaceutical and research chemists on site
• Specialists in Radiopharmaceuticals
• Consultancy and coordination of cGMP synthesis of APIs

Key Contacts

Production and New Business: edith.gubicak@radpharm.com.au
Chief Executive Officer: ross.hanna@radpharm.com.au
Quality & Regulatory Director: jacqui.whitwell@radpharm.com.au