Michelle Brien's Contact Details

Michelle Brien's Company Details

McGee Pharma International, a PharmaLex Company

Portmarnock, Dublin, Ireland • 0 Employees
Pharmaceuticals

We are passionate about putting safe and effective products in the hands of patients.\\We are an award winning pharmaceutical consultancy that combines industry leading EU and FDA quality and technical insight with best-in-class product development and commercialisation knowledge. \\Our unique expertise enables you to maximise innovation and product quality by implementing smarter, practical solutions that allow you to focus on what matters – ensuring your patients receive safe and effective treatment.\\Our services span the entire product lifecycle, from development to post-marketing and product discontinuation. Our services include:\\• Product Lifecycle Management\• GxP Facility Design and Build\• Business Transformation and Metrics\• IT Systems Implementation\• Outsourcing and Tech Transfer\• Quality Management System (QMS) design\• Issue Resolution and Enhancement\• Inspection Readiness / Mock Regulatory Audits\• Marketing Authorisation (MA) Holder Compliance\• Regulatory Affairs\• Product Authorisation Support\• Clinical Trial Strategy, Design and Management\• Qualified Person (QP) and Responsible Person (RP) support\• Risk Management \• Data Integrity\• Pharmacovigilance \• Validation\• Training