Outsourcing Quality Assurance

In today's cost competitive and increasingly stringent regulatory environment, many companies are choosing to outsource quality assurance tasks. This allows easy scaling of the QA function to meet production needs.

In many smaller companies, quality assurance tasks are often added to the responsibilities of personnel who do not have the time, knowledge or experience to handle them. As a result, GMP regulatory compliance and ongoing quality assurance/improvement often does not receive the attention it requires.

Quality Assurance outsourcing is not limited to smaller companies. Multi-national's with established QA departments often need to overcome staffing shortages, have their staff trained or obtain independent advice.

Whatever your situation, we can ensure regulatory compliance, enhance your business process and quality systems, and most importantly, allow you to concentrate on your core business.

Our Outsourcing Quality Assurance (QA) services include:

Full or "as needed" consulting for ISO and/or GMP quality assurance and regulatory affairs.
Audits of your FDA GMP and/or ISO 13485 quality system or a supplier's quality system.
Review of corrective actions and recommendations for resolution.
Attendance at executive management review meetings.
Internal auditor training or other training needs.
Complaint handling, contract review and surveillance audits.
Document control and maintenance.

Why choose PharmOut for your quality assurance outsourcing?

PharmOut is a registered Australian sponsor, with offices throughout the Asia Pacific region.
Quality Assurance is our business. We stay on top of the latest regulatory developments - reading the regulations so that you don't have to.
We can supply staff on short notice, responding to your changing workloads.
Outsourcing QA tasks on an "as needed" basis is more cost effective than hiring staff, with all the associated oncosts.
We have many clients across the Asia Pacific region and have learnt what works and what doesn't in terms of quality management systems (QMS). We can apply what we've learnt to improve your QMS.