Our GMP consultants can assist you with establishing a robust, cost effective quality management system that has a firm basis on proven ISO standards and GMP regulations.
Regardless if your company is just starting off or well established in the Pharmaceutical or Medical Device Industry, PharmOut can help you.
Our experienced professional GMP experts have years of practice experience to share with you.
If you are Pharmaceutical or Medical Device company starting from scratch, it really is a case of a "stitch in time saves nine"!
If you are looking for a head start and need a quality system quickly but are mindful of costs, we can supply templates for policies, standard operating procedures, work instructions and forms. If you don't want to use ours we can advise you where to get proven templates.
However, every company is different and whilst having a set of templates to base your Quality Management System on is a great start; you must customise it to suit your needs and business processes.
PharmOut has experienced Technical Document Writers available to write quality documents for you. By working closely with you, our Continuous Improvement experts (to map business processes) and our GMP Consultants can ensure that the Quality System complies with FDA and Australia's TGA regulations. Not only will they be compliant, they'll be easy to read and follow.
If you are working in a networked environment and use MS Word 2003, PharmOut can show you how to modify your existing template directory and allow you to propagate managed instances of documents right from your desk! At the same time you can lock down your templates and password protect them from deliberate or accidental change.
Is your company well established and you only need a GMP consultant for a short assignment? Why not give us a call. You may be surprised at how quickly PharmOut Australia can add a competent GMP / Quality professional to your team.
Have you audited your vendors as often as you should? Outsource it to PharmOut. We have experienced and professional GMP auditors available to audit on your behalf.
We also offer audit-readiness assessments (download a brochure).
PharmOut can also take on validation projects and execute them quickly. We have experienced and professional Validation Consultants available at short notice.
Whilst we are headquartered in Australia, we offer consulting services to New Zealand and South Africa from our offices there.


Contracted Autoclave Validation