Pharmaceuticals

PharmOut helps pharmaceutical manufacturers in the Asia Pacific comply with PIC/S, FDA or TGA regulatory requirements.

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.More

GxP compliance contracting

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

GMP Compliance Audits - Pharmaceuticals

If you have an impending audit, our ex-TGA auditors can do a mock audit to determine if you are ready or need to make improvements. More

Audit findings responses

If you've just been audited, we can help you formulate your response to the regulator's audit or compliance report. More

Facility design reviews

Before you spend capital on new facilities make sure the design will make GMP compliance easy. More

Supplier audits

PharmOut offers a third party GMP audit service that allows several customers of a specific supplier to share the costs of an audit. More

QMS development

If you need a new Quality Management System (QMS) or updates to an existing one, PharmOut can provide the resouces and expertise.More

 

 

Pharmaceutical Process Validation Services

Pharmaceutical process validation according to the most recent regulations. More

Validation services

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

Validation training

Book classroom training or learn about our eLearning options. More

GMP training

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

Project management

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

Sourcing offshore manufacturers

Find and qualify overseas contract manufacturers and suppliers. More

Drug registration

Registration strategies and submissions for companies wishing to supply drugs into the Australian market. More

Continuous improvement

Learn how we apply the processes used in other industries, such as Lean Manufacturing and Six Sigma within the regulatory constraints of the Pharma industry. More

Recruitment

Get help finding permanent or temporary staff with specific technical skills and experience. More