Pharmaceutical Manufacturers

Pharmaceutical Consultants

PharmOut helps pharmaceutical manufacturers in the Australia, New Zealand and most of Asia Pacific comply with TGA, MedSafe, PIC/S, EU and US FDA regulatory requirements. Our pharmaceutical consultants have a range of skills and experiences to provide niche expertise to your next project.

Our services include:

GxP compliance consulting

We provide PIC/s GMP compliance advice that is based on cost-effective and practical compliance, not just compliance without regard to business demands. ...

GMP Contractors

If you are resource-poor and need experienced, professional GMP contractors to get a job done or a project completed, then we can supply contractors with a range of GMP skills and knowledge ...

GMP Compliance Audits

If you have a regulatory audit coming up, make sure you are ready by having a pre-audit by one of our experienced consultants. ...

Audit findings 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 a ...

Facility design reviews

Getting an independent GMP review of your facility design is a great insurance policy - before the concrete is poured or you've signed the property lease. We've known several companies wh ...

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. As part of this review there is a requirement to assess the G ...

Validation Services

We offer a full range of validation services, from cleaning validation and process validation to computer systems validation. ...

GMP training

PharmOut offers many Validation, GLP, GDP and GMP training courses. ...

GMP Project Management

PharmOut offers project management services to help you get production up and running and comply with the relevant regulations. ...

Drug registration

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 complimentary medicine manufacturers. ...