GMP Compliance, Regulatory Affairs & Validation Consultants

PharmOut offers practical, simple GMP, Validation and Regulatory solutions for companies seeking to obtain a competitive advantage.

Our philosophy is simple, write concise quality systems or validation protocols that tell your team what to do and then make sure you or your team do what you have written.

If you are looking for a GMP Consultants or Validation Consultants that will build quality systems which is a monument to "our technical brilliance" then PharmOut is not for you.

If your are interested, please read more about our range of service below, we offer GMP regulatory advice, practically applied.

What we offer:

People

Outsourced consultants to work on your site under your direction at short notice for short or long duration projects.
We have Pharmaceutical Engineers, GMP Consultants, Validation Consultants, Regulatory Affairs Consultants and Technical Document Writers available at short notice at competitive rates.
We supply Engineers to review your plant design as well as other general engineering services.

GLP/GMP Compliance

GLP/GMP Quality Management Systems or Quality Management Systems or GAP audits and assessments
Practical recommendations and advice on the implementation of ISO 9001 for Pharmaceutical or ISO 13485 for Medical Device Quality Management Systems, Policies, SOP and Forms.
Pharmaceutical Maintenance we can audit your engineering department for compliance to TGA, FDA and ISPE baseline recommendations.
We assist with Veterinary Drug GMP compliance to the APVMA GMP code.

Validation - Process, Equipment & Computer

Pharmaceutical and Medical Device Process Validation to TGA and FDA regulations,
Pharmaceutical Equipment Validation to international regulatory standards and in accordance with current Good Manufacturing Practice.
Cleaning validation for pharmaceutical and medical device manufacturing facilities

Regulatory Affairs - Medical Device / Drug registration

Providing advice and answering your questions on the Australian TGA's medical device / drug registration process
Preparing dossiers to support a drug registration with the TGA

Continuous Improvement - Lean Manufacturing, Six Sigma

Continuous Improvement projects are difficult to initiate and implement as the highly regulated Pharmaceutical environment. Why not talk to PharmOut experts, knowledgeable in both Continuous Improvement and GMP requirements.

Training - Pharmaceutical, Medical Device & Veterinary

We offer a wide range of GMP training and GLP training courses.

More about our services

Who we are:

Headquartered in Melbourne, Australia we operate throughout the Asia Pacific region. PharmOut consultants each have many years of experience in the pharmaceutical, veterinary or medical industries. Experience that has seen most of the problems that can occur in facility design, scale up development and manufacturing. Experience that can prevent you making mistakes - or solve them if it is too late.

As consulting professionals it is our job to stay up to date with current regulations so that we can be sure our customers comply. Have you got time to read them all, let alone ensure that you comply?

Who will benefit from our services?

Business results focussed Quality Assurance, Manufacturing and Engineering Professionals within pharmaceutical, veterinary or medical device companies looking to improve GMP compliance and enhance business profits.

Australia | China | New Zealand | Singapore | South Africa

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