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.