Consulting

Essjay Solutions offer consulting services for all pharmaceutical companies regardless of size, across the UK. These services include report writing, training, audit and process reviews, inspection support and resource analysis.

Report Writing

Essjay Solutions have access to a network of medical writers and can provide and manage your pharmacovigilance report writing, including PBRER, DSUR and RMP reports. Whether you require a section to be managed and written or the report in its entirety, we are able to offer assistance.

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PBRERs

When a new product is approved, safety and efficacy is based on studies from a limited number of patients and population, where high risk patients are often excluded. Additionally monitoring is intensive, enabling safety data to be collected throughout the development programme.

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DSURs

During clinical development of an investigational drug, periodic analysis is critical to ensure risks to study patients are identified and managed appropriately. The DSRU is a comprehensive annual review and evaluation of pertinent safety information collected during a specified reporting period for a drug under investigation, whether or not it is marketed.

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RMP

At the time of authorisation, information on safety is relatively limited due to the numbers exposed during clinical studies and the limited patient population studied. The product will have a positive benefit: risk for a specific population in a specific indication at time of approval.

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Training

Essjay Solutions run tailored training sessions that are specially formulated to match the needs of your business. PV regulation insists that all training is documented especially for specific job roles and we can prove competency through detailed and relevant courses.

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Audit and Process Review

We offer comprehensive auditing services including internal inspections of processes, risk management strategies and reports to help you offer the highest quality services and products.

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Inspection support

Assist your company with preparation for impending PV inspections, including training up your company’s employees, rehearsal inspections and remedial inspection plans

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Discover how Essjay Solutions can help you
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