The Lewis David Consultancy Ltd
Providing expert advice and services to global biopharmaceutical companies and Clinical Research Organisations (CROs).
Primary Services
Strategic PV and Regulatory Advice
We can provide strategic advice regarding the PV component of your regulatory strategy
including support during EU Marketing Authorisation Application procedures, including
helping you to respond effectively and efficiently to Regulatory Agencies List of Questions
(LoQs) from day 70/80 to end of procedure.
NEW: Advanced Therapy Medicinal products (Gene and Cell Therapy)
We provide strategic guidance regarding analysis of safety data related to ATMPs including
safety data from cell and gene therapy clinical studies, handling post-marketing data related
to ATMPs and formulating risk management plans and risk mitigation strategies for handling
safety data relating to ATMPs.
Medical Review and Safety Analysis
We provide expert advice on any safety issues including drafting responses to regulatory
authority queries regarding new and emerging safety issues which require investigation and
resolution. We will help you to craft your responses so that your messaging is clear and
precise and in line with regulatory agency expectations.
Signal Detection/Signal Management
We will use of decades of regulatory pharmacovigilance experience and know how to help
you design and build and implement a Signal Detection/Signal Management system that is fit
for purpose and compliant with international regulatory standards and regulatory
requirements. We will also carry out signal detection/signal management activities on your
behalf while you develop in-house expertise.
PV System Gap Analysis
We will carry out a thorough onsite PV Gap Analysis so that we can ascertain the regulatory
compliance and readiness of your current PV system and provide advice about the gaps that
need to be address to ensure regulatory compliance. The Gap Analysis will be accompanied
by a detailed report which will describe all of the components of a complaint PV system and
indicate where you need to make adjustments to become compliant. We will also provide
you with an Implementation Plan so that you can adopt a strategic approach to making your
PV system effective.
PV System Design and Implementation
We can help you design a PV system that will meet your immediate but also scalable as your
portfolio grows. We will guide you through the PV system requirements and advise you on
the best model for your company such as an in-house model, outsourced model or a mixed
model consisting of in-house/outsourced components. We will make sure the right experts
are available when you need them and we will help to transition to your new PV system by
crafting an implementation plan which meets your needs and which fits in with your
milestones.
PV Training and Workshops
All personnel involved in the performance of pharmacovigilance activities in an organisation
must receive initial and continual pharmacovigilance training. We can provide bespoke
onsite PV training covering all aspects of PV and drug safety and which is tailored to your
needs. We can conduct workshops which concentrates on a particular area of PV and Drug
Safety so that you and your staffs can spend some time developing a more in-depth
understanding of a particular topic.
Pharmacovigilance Quality Assurance
We offer support to small, medium sized and large biopharmaceutical companies in
developing and establishing pharmacovigilance Quality Management Systems (QMS) based
on international requirements and the requirements set out in Module I of the European
Commission’s Good Vigilance Practices (GVP). We will also help you maintain your QMS
once it is in place by providing PV Audits and handling any corrective actions and
preventative actions (CAPA) in a timely manner.
Regulatory Document Writing
We provide a high quality regulatory document writing service covering all regulatory reports
including but not limited to:
Development Update Reports (DSURs)
Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports
(PBRERs)
Risk Management Plans (RMPs)
Risk Evaluation and Mitigation Strategies (REMS)
Pharmacovigilance System Master File (PSMF)
Pharmacovigilance System Summary (SPS)
Standard Operating Procedures (SOPs)