GMP Consultants, Validation, Engineers & Architects

GMP Consultants, Qualification & Validation, Engineers & Architects

PharmOut is a rapidly growing international consultancy offering GMP compliance, qualification & validation, TGA regulatory, engineering and architectural consulting services to the pharmaceutical, blood & tissue, pesticides and veterinary and medical device manufacturers, as well as related hospital and pharmacy operations.

PharmOut holds ISO 9001:2015 certification from LQRA. Our Quality Management System is certified to the ISO 9001:2015 standard for the provision of architectural design and consultancy services.

We aim to give you a competitive advantage by helping you design, build and operate manufacturing facilities that will fully comply with international Good Manufacturing Practice (GMP) regulations as issued by regulatory agencies such as the US FDA, MHRA, CFDA and PIC/S member agencies such as the Australian TGA, New Zealand MedSafe, Singaporean HSA to list a few of the nearly 50 PIC/S member agencies.

As one of the regions leading pharmaceutical consulting companies, our expert GMP consultants, GMP trainers, pharmaceutical engineers and architects provide practical, cost effective GMP compliant design solutions, which have a focus on improving your bottom line across the entire life cycle of your products.

PharmOut works closely with our sister company, QikSolve, a leading Australian SharePoint consultancy providing SharePoint eQMS system Ibiqs for regulated companies.

Need to Validate SharePoint, or an eQMS? More >

What PharmOut offers:

QA and GMP consulting

Trevor Schoerie - Engineering, Validation and GMP Consultant

Pharmaceuticals – Our GMP consultants can offer practical knowledge and experience on implementing or enhancing your Pharmaceutical Quality Systems (PQS) to meet GMP code requirements and those based on ICH Q10 / ISO 9001:2015 for Pharmaceuticals. PharmOut will work from a series of templates and experiences based on many successful past projects and quickly install policies, procedures, work instructions and records. More >

GMP audits – We help with GLP, GMP gap audits / assessments and remediation plans to help you prepare for successful GMP audits and inspections from agencies such as the TGA/MHRA/US FDA. More >

Medical devices / IVDs – We understand, and have implemented a number of ISO 13485:2016 (old ISO 13485:2003) Quality Management Systems for medical device manufacturers as well as implementation to meet US FDA 21 CFR Part 820 requirements in the past few years. More >

Blood and tissue – Our GMP consultants can advise on blood and tissue GMPs, including the country-specific GMPs like those issued by the TGA or Annex 2 from the EU and PIC/S codes of GMP. More >

Pesticide and veterinary drug – We can assist with GMP compliance to the US FDA, EU and the APVMA GMP codes. More >

Qualification and Validation of facilities, utilities, systems, equipment and computerised systems

Architectural and engineering consulting services

  • We can design world class health science facilities such as hospitals, aged care units, GMP-regulated manufacturing sites and scientific laboratories.
  • Our engineering staff are experts in facility and clean room design and classification. They will ensure that work done on clean rooms adheres to the correct standards, helping to avoid costly mistakes.
  • Our facility design review services will ensure regulatory compliance and efficient workflows within a facility.

GMP training, On-site and Public training for the pharmaceutical, biotech, medical device & veterinary industries

Regulatory affairs – medical device / drug registration

Continuous improvement – lean manufacturing, Six Sigma

PharmOut’s pharmaceutical engineers have years of manufacturing and regulatory compliance experience. They are experts in managing continuous improvement projects, which are often difficult to initiate and implement in the highly regulated pharmaceutical environment. Why not talk to PharmOut experts, knowledgeable in both continuous improvement and GMP requirements?

Our people

If you need human resources for a project, we have:

Pharmaceutical consulting company

PharmOut operates internationally with local offices around Australia (Adelaide, Melbourne, Sydney and Brisbane), Hong Kong, UK and New Zealand.

PharmOut’s Pharmaceutical Engineers, Architects and Consultants each have many years of experience in the pharmaceutical, biotech, pharmacy, veterinary and medical device 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 help you 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? Are you sure you are compliant?