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.
GMP Project Management
PharmOut offers project management services to help you get production up and running as well as in compliance with the relevant industry regulations.
Pharmaceutical Consulting Services
We can help with determining which regulations you need to comply with and how to achieve compliance without sacrificing business success.
GMP Compliance Audits
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.
Facility Design Reviews
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.
Audit Findings and Responses
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.
Vendor Assurance / Supplier Audits
GMP vendor management audit program The PIC/S GMP code (and the FDA) specifies that product quality reviews must be undertaken.
Pharmaceutical Vendor Management Program
We can help you find and qualify overseas manufacturers and suppliers.
Registration strategies and submissions for companies wishing to supply drugs into the Australian market.
Quality Management System
PharmOut offers a range of services and products aimed at delivering QMS compliance for pharmaceutical manufacturers.
Continuous Improvement Consulting Services
Learn how to apply processes such as Lean Manufacturing and Six Sigma within the regulatory constraints of the Pharma industry.
Interim QA Managers and GMP Staff
Get help finding permanent or temporary staff with specific technical skills and experience.
PharmOut offers many Validation, GLP, GDP and GMP training courses online as well as in a city near you.
If you have questions you would like to ask, please contact us contact us at one of our offices around the world.
If you want to read more about topics relating to pharmaceuticals, why not check out our blogs?