The Lewis David Consultancy Ltd

Drug Safety, Pharmacovigilance and Risk Management Specialist

Pharmacovigilance, Drug Safety and Risk Management consultancy based in London, UK

The Lewis David Consultancy is a Pharmacovigilance, Drug Safety and Risk Management consultancy based in London, United Kingdom. The company is led by Morell David who is a UK MHRA-trained Pharmacovigilance expert and who has more than 25-years’ experience in all aspects of Pharmacovigilance, Drug Safety and Risk Management Planning.

Our Services

Our cost-effective
services cover all areas of pharmacovigilance, drug safety and risk management planning
including:

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Advanced Therapy Medicinal Products (ATMPs)

We carry out safety assessments and benefit-risk profiling of ATMPs including cell and gene
therapies. We will provide strategic advice regarding handling emerging safety issues
relating to ATMPs that are either in clinical development or marketed products.

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Strategic PV & Regulatory Advice

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Medical Review & Safety Analysis

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Signal Detection/Signal Management

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PV System Gap Analysis

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PV System Design and Implementation

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PV Training and Workshops

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Pharmacovigilance Quality Assurance

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Regulatory Document Writing

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Development Safety Update Reports (DSURs)

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Pharmacovigilance System Master File (PSMF)

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Signal Detection/Signal Management

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Risk Management Plans (RMPs) and Risk Evaluation & Mitigation Strategies (REMS)

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Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs)

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Development Safety Update Reports (DSURs)