the eu regulatory process accelerating and innovating compliant … · 2017. 12. 13. · mcgee...

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accelerating and innovating compliant patient care Service Information McGee Pharma International is an award winning EU and US Quality, Technical and Compliance consultancy to the life sciences industry. Our team of expert consultants, comprising a number of former EU and US FDA Regulatory Inspectors, works at a strategic and tactical level with our clients, providing solutions, holistic advice and guidance across the entire product lifecycle. With a global network of over 90 GxP consultants, we have the bandwidth and expert capability to support the diverse demands facing our clients. In addition to providing unrivalled industry and regulatory insights, we work with your teams to implement recommendations and solutions with the goal of establishing sustainable compliance in your operations. The EU Regulatory Process Whether you are seeking to license your product or establish your operations in the EU, McGee Pharma International is excellently placed to support you in navigating the EU regulatory process. Our team of consultants, comprising a number of former EU Regulatory Inspectors, has successfully supported clients in obtaining: » Manufacturers / Importers Authorisations (MIAs) » Marketing Authorisations (MAs) » Wholesale Distribution Authorisations (WDAs) For further information visit mcgeepharma.com or contact our team at [email protected] 1st Floor, Stafford House, Strand Road, Portmarnock, Co Dublin T | +353 (0)1 846 4742 F | +353 (0)1 846 4898 E | [email protected] W | www.mcgeepharma.com

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Page 1: The EU Regulatory Process accelerating and innovating compliant … · 2017. 12. 13. · McGee Pharma International is an award winning EU and US Quality, Technical and Compliance

accelerating and innovating compliant patient care

Service Information

McGee Pharma International is an award winning EU and US Quality, Technical and Compliance consultancy to the life sciences industry. Our team of expert consultants, comprising a number of former EU and US FDA Regulatory Inspectors, works at a strategic and tactical level with our clients, providing solutions, holistic advice and guidance across the entire product lifecycle.

With a global network of over 90 GxP consultants, we have the bandwidth and expert capability to support the diverse demands facing our clients. In addition to providing unrivalled industry and regulatory insights, we work with your teams to implement recommendations and solutions with the goal of establishing sustainable compliance in your operations.

The EU Regulatory Process

Whether you are seeking to license your product or establish your operations in the EU, McGee Pharma International is excellently placed to support you in navigating the EU regulatory process.

Our team of consultants, comprising a number of former EU Regulatory Inspectors, has successfully supported clients in obtaining:

» Manufacturers / Importers Authorisations (MIAs)

» Marketing Authorisations (MAs)

» Wholesale Distribution Authorisations (WDAs)

For further information visit mcgeepharma.com or contact our team at [email protected]

1st Floor, Stafford House, Strand Road, Portmarnock, Co DublinT | +353 (0)1 846 4742 F | +353 (0)1 846 4898E | [email protected] W | www.mcgeepharma.com