PharmOut helps medical device manufacturers in the Asia Pacific comply with requirements and standards, issued by organisations such as ISO, GHTF, FDA, EMA etc.
Our services include:
We provide compliance advice that supports both your regulatory requirements and business demands. More
Before you spend capital on new facilities make sure the design will make both compliance and manufacturing easy.
Our auditors can perform a mock audit to determine if you are ready for a regulatory conformity assessment, or need to make improvements.
If you've just been audited by a regulator, we can help you with your response to the audit compliance report.
We offer a full range of validation services, from process validation to computer systems validation.
PharmOut offers a third party audit service that allows several customers of a specific supplier to share the costs of an audit. We can also perform on-demand audits of your suppliers. More
PharmOut offers project management services to help you get production up and running and comply with the relevant regulations.
Get help finding permanent or temporary staff with specific technical skills and experience.
If you need a new ISO:13485 or QSR 820 compliance Quality Management System (QMS) or updates to an existing one, PharmOut can provide the resouces and expertise. More
PharmOut's training courses range from an Intro to ISO 13485 to Validation and Auditing. Book classroom training or learn about our eLearning options.