GMP consulting services

Looking for GMP Consulting Services?

PharmOut’s GMP consulting services are provided by our international Good Manufacturing Practice cGMP consultants and experts. Many have previously held roles within regulatory bodies such as the Australian Therapeutic Goods Administration  (TGA). They are able to consult on GMP compliance and quality assurance (QA) related issues.

PharmOut is a specialist medical device and pharmaceutical consultancy. We provide 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

Why do you need GMP consulting services?

If you are a young pharma, life science or medical device company you will probably need help navigating the complexities of the GMP regulations. Which regulations to comply with? (there are many!). How to comply as easily and cheaply as possible? Which IT systems should you spend money on and which processes should you do manually until you have more funds? Having an auditor find noncompliances on your site can be a very expensive way to discover that you don’t have the depth of knowledge or experience inhouse to manage GMP compliance. Investing in a cGMP consultant to help you early in your product’s or facility’s lifecycle will prevent expensive mistakes. The investment will pay for itself over and over again as you enjoy buildings and systems that make compliance easy.

If you are an established business you may need help with recovering from non-compliance issues resulting from an audit or help with designing a new GMP facility.  We can even provide ‘back-fill’ staff to cover periods of absence or resource shortfalls on projects.

GMP consulting services PharmOut provides

With over 50 consultants within PharmOut, we are the largest provider of GMP consulting services in the region. We can offer:

  • cGMP consultants for high level strategic consulting on GMP compliance
  • Consultants to advise on the continuous improvement of manufacturing processes
  • Onsite cGMP consultants to design and implement GxP-compliant processes and systems
  • Training on regulatory GMP compliance
  • Help with registering products with the TGA
  • Resources to design and complete qualification & validation tasks
  • GMP facility design and construction
  •  Interim human resources

and much more.

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 ...

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 ...

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 ...

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 ...

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) ...

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 ...

Auditing Services

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