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.
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.
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.
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.
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.
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.
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.
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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