PharmOut offers a range of industry solutions including Architectural, Compliance, Engineering, GMP, QA, Technical Writing and Validation Services to Healthcare, Medical Device, Pharmaceutical and Veterinary industries to facilitate Good Manufacturing Practices (GMP) and enhancing operational efficiency. PharmOut also has a proven record of delivering successful projects in the food, dairy and cosmetics manufacturing industries throughout the world. These services can be offered on a fee for service or a fixed price basis.
We have designed, built, validated and facilitated the operation of Blood and Tissue banks and Biological (ATMPs) manufacturing plants and clean rooms.
We offers a variety of services to manufacturers of complementary medicines who would like to achieve TGA certification or obtain a manufacturing license.
A number of our consultants have also worked in the cosmetics industry and we have assisted in the setting up of manufacturing facilities of cosmetics companies from scratch – from the initial designing and building of the facilities all the way to getting production on its feet.
We can help researchers working in health science research laboratories in the Asia Pacific comply with the requirements of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) by designing and engineering exceptional laboratories to work for the researcher.
PharmOut has a large collection of online training modules and offers a variety of training options to suit your needs in the form of public courses, eLearning and on-site.
We can provide guidance on In Vitro Devices (IVDs). These are typically treated as a subset of medical devices and provide information for diagnostic, monitoring or compatibility purposes.Medical Device Manufacturers
Our consultants are experienced at implementing Quality Management Systems to ISO 13485 compliance and we have a huge library of past projects and wealth of experience to draw upon.
We can offer guidance on how to obtain licenses for the cultivation, production and manufacture of medicinal cannabis as well as provide facility design and engineering expertise to suit your requirements.
We are able to offer a wide range of GMP services to the Pesticide and Veterinary industries, including APVMA regulatory consulting, facility design, engineering, validation, technical writing and auditing.
PharmOut consultants help pharmaceutical manufacturers within Australia, New Zealand and most of the Asia Pacific region in complying with regulations issued by various authorities.
PharmOut has helped a number of pharmacies achieve Australian TGA and other agency GMP certifications. To date we have been involved in: radio-pharmacies, oncology, sterile and non sterile manufacture as well as TPNs and dose aid and animal products.
We work closely with our sister company, QikSolve, who provide a SharePoint-based electronic Quality Management System (eQMS) that complies to the FDA CFR Part 11. This Ibiqs system can be used to manage controlled documents in a regulated GMP facility.