GxP compliance consulting

Looking for GMP Consultants?bob tribe gmp consultants

PharmOut’s team includes international GMP consultants and experts who have previously held leadership roles within regulatory bodies and are able to consult on GMP compliance and QA other related issues.

We provide interim resources, GMP consulting and training on regulatory GMP compliance, product registration, qualification & validation and continuous improvement of manufacturing processes and facility design and construction.

PharmOut a specialist device and pharmaceutical consultancy, provides GMP consulting services to those industries subject to PIC/S, European (EMA), US (FDA), MedSafe and Australian (TGA), drug and medical device regulations, such as the US FDA 21 CFR Part 820, and the ISO 13485 Quality Management System for Medical Devices and ISO 14971 Risk management for medical devices. 

 

Compliance strategy development

GMP compliance can be tricky - which regulations, which interpretation, where to start? We can help you develop a GMP compliance roadmap. ...

GMP Compliance Audits

If you have a regulatory audit coming up, make sure you are ready by having a pre-audit by one of our experienced consultants. ...

Quality Management System

PharmOut offers a range of services and products aimed at delivering QMS compliance for complimentary medicine manufacturers. ...

Validation Consultants

Validation Consultants / Engineers Experienced in FDA, EU and PIC/S GMPs PharmOut frequently executes validation projects on a fixed price basis or offers our experienced Validation Consu ...

21 CFR Part 11 / Annex 11 compliance

US FDA CFR Part 11 Compliance / EU Annex 11 Compliance US FDA CFR Part 11 compliance means complying with the regulatory requirements for Electronic Records and Electronic Signatures (ERES) ...

Vendor Assurance / Supplier audits

GMP vendor management audit program The PIC/S GMP code (and the FDA) specifies that product quality reviews must be undertaken. As part of this review there is a requirement to assess the G ...

Audit findings responses

Receiving a notice of deficiencies after an audit by a regulator is never pleasant. For some companies it will mean major remediation efforts are required, for others it may mean having to a ...

Facility design reviews

Getting an independent GMP review of your facility design is a great insurance policy - before the concrete is poured or you've signed the property lease.We've known several companies wh ...

Auditing Services

We offer a range of Auditing options for a number of industries ...

TGA Regulatory Affairs Consultants

We offer registration strategies and assistance with submissions for companies wishing to supply drugs or devices into the Australian market. ...

Australian TGA Consultants

Australian TGA consultants for Drug, Veterinary, Medical Device and IVD manufacturers PharmOut employs a number of  ex-Australian Therapeutic Goods Administration (TGA) inspectors as TGA c ...