The Lewis David Consultancy Ltd

Providing expert advice and services to global biopharmaceutical companies and Clinical Research Organisations (CROs).

Morell_David_LDC

About Our Practice

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.

The company provides expert advice and services to global biopharmaceutical companies and Clinical Research Organisations (CROs).

We provide a range of tailored pharmacovigilance, drug safety and risk management services to all biopharmaceutical companies, regardless of size and trading history. 

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 (Gene and Cell Therapy)

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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)