About Us
CONSULTING WITH PURPOSE
Projects can be challenging, and sometimes you need additional expertise; we're here to lighten the load and get results. Our services are customised to meet the specific needs of each client. We work collaboratively throughout the entire process and guarantee measurable results.
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White Hart Consultants provide quality and operational expertise to a wide range of clients engaged in pharmaceutical development, and specialise in Advanced Therapy Medicinal Products (ATMPs).
We are based in the UK, in Hertfordshire, an ideal location for the UK ATMP cluster and 'Golden Triangle' networks in the Southeast - get in touch today and see how we can help you or follow us on LinkedIn.
About Me
HELEN M. MURRAY, BSC (HONS) MBA CBIOL MRSB MRQA
White Hart Consultants Ltd was founded by Helen Murray, who has more than twenty years’ experience in the biotech / pharmaceutical industry, in GMP- GCP- and GDP-regulated environments, and has a strong background in drug development and clinical trials.
Specialising in the manufacture, control and release of biological Investigational Medicinal Products (IMPs) and Advanced Therapy Medicinal Products (ATMPs), with experience in innovative cell and gene therapy products (autologous and allogeneic cell-based products, oncolytic viruses and AAV vectors), Helen has worked for a diverse range of organisations as a consultant, and in QC, QA, Manufacturing and site leadership roles where she has successfully established and led high performing teams in fast-paced, growing start-ups.
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Helen is eligible to act as a Qualified Person (QP) under the permanent provisions of EU Directive 2001/83/EC, and as a Responsible Person (RP), and recently completed her MBA (Master of Business Administration), achieving a distinction; she is ideally positioned to provide the perfect combination of proven operational business and technical operations expertise.
Helen is a Chartered Biologist and a member of the Royal Society of Biology (RSB), the Research Quality Association (RQA) and Parenteral Drug Association (PDA).
Services
PROFESSIONALISM . PRAGMATISM . PERFORMANCE
Quality Management Systems (QMS)
QMS design, implementation and optimisation projects
Policy and SOP writing and reviewing services
Drafting and reviewing Technical Agreements
Inspection Readiness Support
Gap analyses
Mock inspections
Personnel training and coaching
Pre- and post- inspection support
Interim Management
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Senior interim Quality/ Technical Operations support
Global Audits and Due Diligence
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CDMO evaluation and selection projects
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Generation of risk-based audit schedules
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GMP and GDP auditing services
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Vendor performance management and troubleshooting
Quality Consultancy and Training
Conduct of impartial 'internal' audits
Documentation reviews
Investigation support and troubleshooting
Delivery of in-house training
Additional Technical Services
Process optimisation projects
Technical GMP QA support - complex investigations, technology transfers, batch manufacturing record (BMR) review
Qualified person (QP) and Responsible Person (RP) services also available
Contact Us
Have a particular challenge you’re trying to deal with? Contact us today and see how we can help.