PharmOut helps pharmaceutical manufacturers in the Australia, New Zealand and most of Asia Pacific region comply with TGA, MedSafe, PIC/S, EU and US FDA GMP regulatory requirements. Our pharmaceutical consultants, architects, engineers and scientists have a wide range of skills and experiences to provide niche expertise to your next project at any stage.
If you are resource-poor and need experienced, professional GMP contractors to help get a job done or a project completed, then we can supply contractors with a range of GMP skills and knowledge.
We can help with determining which regulations you need to comply with and how to achieve compliance without sacrificing business success.
PharmOut is privileged to have several consultants who have had years of experience as TGA and PIC/S auditors. They know the relevant international regulatory codes for Pharmaceutical Manufacture.
If you already have a facility design, we can provide an independent GMP review to make sure that all the important details are covered and nothing has been missed before the property lease is signed and the cement is poured.
Receiving a notice of deficiencies after an audit by a regulator is never pleasant. For some companies it will mean major remediation efforts are required, for others it may mean having to address a few small issues. PharmOut can help you prepare your audit response.
We offer a full range of validation services, from cleaning validation and process validation to computer systems validation.
Learn how to apply processes such as Lean Manufacturing and Six Sigma within the regulatory constraints of the Pharma industry.