PharmOut offers specialist GMP consulting services to the medical device and pharmaceutical industries. As a leading GMP consultancy, we provide these 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.
PharmOut’s GMP consulting services are provided by our international Good Manufacturing Practice cGMP consultants and experts. Many in our team have previously held roles within regulatory bodies such as the Australian Therapeutic Goods Administration (TGA) and they are able to consult on GMP compliance and quality assurance (QA) related issues.
Consulting services typically requested by clients include:
21 CFR Part 11 / Annex 11 Compliance
US FDA CFR Part 11 compliance means complying with the regulatory requirements for Electronic Records and Electronic Signatures (ERES) as outlined in the US Code of Federal Regulations (CFR) Part 11, or those documented in EU or PIC/S Annex 11. As experienced GMP consultants, we can help.
Audit Findings and 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 address a few small issues. Our GMP consultants can help you prepare your GMP Audit Response.
We offer a range of auditing options for a number of industries which can cover GMP Compliance, Regulatory Inspections and Post-Audit Remediation Programs all to TGA, FDA and EMEA standards.
Australian TGA Consultants
PharmOut employs a number of ex-Australian Therapeutic Goods Administration (TGA) inspectors as experienced GMP consultants and we can help you with obtaining regulatory approval from the TGA.
Compliance Strategy Development
GMP compliance can be tricky – which regulations, which interpretation, where to start? We can help you develop a GMP compliance roadmap to guide you on your way.
Facility Design Reviews
If you already have a facility design, we can provide an independent GMP review to make sure that all the important details are covered.
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.
PharmOut offers a wide variety of GLP, GDP and GMP training courses, all of which can be delivered on-site or online, as well as in a city near you.
Quality Management System
More recently now referred to as Pharmaceutical Quality System (PQS), PharmOut offers services and products in the form of professional technical writers and document templates all aimed at delivering and effective and compliant QMS for your site.
TGA Regulatory Affairs Consultants
We offer registration strategies and assistance with submissions for companies who wish to supply products to the Australian market but are unsure of the regulatory requirements.
PharmOut frequently executes validation projects on a fixed price basis or can offers our experienced Validation Consultants Engineers at an hourly rate basis to work at your site.
Vendor Assurance/Supplier Audits
The PIC/S GMP code (and the FDA) specifies that product quality reviews must be undertaken. PharmOut can help you set up a GMP vendor management audit programme to assess the GMP compliance of suppliers.
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 from a gxp compliance contracting company like ours. 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? Which processes should you do manually until you have more funds?
Having an auditor find non-compliances on your site can be a very expensive way to discover that you don’t have the depth of knowledge or experience in-house to manage GMP compliance. Investing in a cGMP consultant early on in your product or facility’s lifecycle will help to prevent expensive mistakes. The initial investment will pay for itself over and over again as you enjoy buildings and systems that make compliance easy.
If you are already 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.
What PharmOut provides
With over 50 consultants, we are the largest provider of GMP consulting services in the region. Examples of what we can offer include but are not limited to:
- 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 or gxp compliance contracting resources
- and much more!