15th July 2013
July Member of the Month: Pharmallaney
Pharmallaney Ltd was established near Abergavenny in 2010. Based upon 25 years of experience in Quality Assurance and Control within the pharmaceutical industry it delivers efficient and effective compliance and management support to individuals or organisations on either a local, national or global basis.
Having worked with organisations small and large across a wide range of products and fields, Pharmallaney prides itself on a pragmatic yet professional approach tailored to the needs of its clients. We understand the pressures of timelines, commitments, goals and budget constraints, working to deliver realistic outcomes that ensure the right high quality results every time. We deliver this through strategic know how whilst ensuring patient safety and compliance. This is achieved by channelling the breadth of experience into focussed objectives.
Specific services provided include:
• Qualified Person (QP) role fulfilment under the permanent provision to meet 2001/83/EC and 2001/20/EC
• QP certification- support of product certification in phase I to III clinical trials or licensed medicinal products, approval of medical devices
• Management or mentoring of departments or specific personnel
• Training- programmes developed to suit needs of pharmaceutical companies including awareness of legislation and basic training as needed
• Inspection interface with regulatory authorities including those of the USA FDA (CDER and CDRH) or MHRA (GMP and GDP)
• Audits- supplier verification and management; active pharmaceutical ingredients, excipients and packaging; contract manufacturers/laboratories; wholesale dealers/brokers; self- inspections
• QMS support and regulatory compliance including gap analysis for medical devices and pharmaceutical
We have a discussions forum on our website www.pharmallaney.com . The first investigates the interplay between the world of Pharmacy and the Qualified Person and explores how the services Pharmallaney offer could benefit the pharmaceutical industry, hospitals, community pharmacies and various other parties engaged in the world of pharmaceutical products.
We seek collaboration with MediWales members to support local companies in Wales, improve awareness of the services we offer, develop business relationships and explore opportunities for the future. Recent engagement includes involvement with the Welsh QP Forum where QP’s from local Welsh businesses gather to exchange information and provide a mechanism for networking and continued professional development. A new venture includes supporting the University of Heads of the Valley Initiative to improve education in the pharmaceutical sector by delivering expert knowledge to the course structure and delivery; course attendees include candidates from MediWales. Pharmallaney has also supported Welsh Government schemes utilised by local companies in order to meet training needs.