PharmOut has a proven track record in helping pharmacies and distribution centres achieve TGA and PIC/S certification and we have noticed that modern pharmacies have started to expand the range of their services and operations. This can be a challenging process and if you are a well established business or just starting up we have a variety of services available that range from architectural and engineering services to help with the initial design and construction of your facility all the way through to document writers and validation contractors to help set up your facility and get it up and running (as well as in compliance with the relevant regulations!).
If you are a Community Service Obligation (CSO) Distributor, we can help you with compliance matters related to the TGA’s Good Wholesaling Practice regulations.
If you are planning a non-pharmacy facility for automated dose packing systems, we can help you get the regulatory approvals as well as show you how to reduce costs and improve efficiencies.
If you are a compounding pharmacy, making non-sterile products and want to upgrade your pharmacy licence to a TGA licence, we can help you achieve a competitive edge and assist you in obtaining that crucial regulatory approval.
If you are a sterile compounding pharmacy looking to transition from a pharmacy licence to a TGA licence,. we can help you obtain regulatory approval or comply with the GMP relating to the manufacture of sterile products.
PharmOut’s TGA Regulatory Affairs Consultants can support you every step of the way to enable the supply of your products to the Australian market.
Our architects and engineers have extensive experience in designing a wide range of industrial facilities suitable for compounding, manufacturing and distribution activities