Services
GMP Consultants
We consult and train on regulatory GMP compliance, product registration, validation and continuous improvement of manufacturing processes.
PharmOut consults to those industries subject to European (EMA), U.S. (FDA) and Australian (TGA), drug and medical device regulations.
PharmOut's team includes international GMP experts and consultants who had previously held leadership roles within regulatory bodies.
Compliance strategy development
GMP compliance advice that is based on cost-effective and practical compliance, not just compliance without regard to business demands. More
GMP Compliance Audits
Called 'GMP Mock Audits', 'Pre-audit Audits', 'GMP Gap Analysis' or 'Pre-regulatory audits', a GMP Compliance Audit is conducted by someone external to your organisation with the purpose of discovering GMP deficiencies. More
21 CFR Part 11 / Annex 11 compliance consulting
If you are implementing a computer system and want advice on if it needs to be compliant to the 21 CFR Part 11 electronic signatures regulation and how to achieve this, we can help. More
Audit findings responses
If you've received an audit report and now need to prepare your response, we can help you achieve the best outcome. More
Regulatory Affairs Consultants
PharmOut consultants specialise in the Australian TGA's requirements and can help you with your questions regarding registration strategies. More
QMS consulting
If you are setting up a new QMS or yours is inadequate, our consultants can advise you on the best way to structure, implement and maintain a QMS. More
Validation Consultants
If you need help with determining what to validate, when and how to do it, or perhaps a review of your current validation, our Validation Consultants will use a risk based approach to develop a Validation Master Plan and practical tips to meet your needs. More
Supplier / Vendor audits
If you are struggling to keep up with auditing your suppliers we offer a supplier audit service, including an economical shared audit service. More
Facility design review
Will your proposed new or upgraded facility meet the GMP requirements of all the countries you supply to? More