Coordination and Collaboration ensures success

Essjay Solutions were approached by a pharmaceutical company who required help with a Registry Study requested by the European Medicines Agency (EMA). The study was to access the long-term effects of a drug. Essjay Solutions begun by carrying out a range of groundwork which included assessing what registries were available and what was retrievable from the registries to see what data could be used effectively. Following this Essjay Solutions worked with the company to produce a protocol synopsis that detailed the study methodology, primary objectives of the study and how these would be measured.

Essjay Solutions worked with academic and university partners to provide expert input into study management as the academic partner had performed this type of study previously but do not have the experience of a study sponsored by a pharmaceutical company. Essjay Solutions helped to ensure a successful collaboration between the pharmaceutical company and the academics in order to achieve the final goal of a compliant scientifically sound post-authorisation safety study that meets the needs of the EMA.

Neubourg Pharma

Neubourg Pharma was formed in 2014 and set up in the UK to provide a treatment and prevention product for diabetic foot syndrome. They are an ethical and consumer healthcare brand that wanted to ensure they were keeping the MHRA informed and adhering to all the necessary regulations, relevant to devices and direct to consumer sales.

The Requirement

Medical devices do not have the same sign off needs and processes as medicinal products but Neubourg Pharma wanted to ensure that they were being prudent and felt safe, therefore they asked Essjay Solutions to come in and manage their processes.

Why they choose Essjay Solutions

The personal touch Neubourg Pharma got from Essjay Solutions was an important reason for their choice and ongoing utilisation of their services. The friendly approach and trust Neubourg Pharma feel with Essjay Solutions onboard has been vital.

Essjay Solutions’ Expertise

Essjay Solutions help with Neubourg Pharma in a number of different areas. From supporting processes, medical information and sign-off material to dealing with queries from consumers and medics. Essjay Solutions set up the full process to ensure that Neubourg Pharma are covered for any eventuality. It can be a minefield with all the different legislation but Essjay Solutions ran a highly comprehensive training programme for all staff within the company.

“Dr Jaitly ran an excellent training session for all our staff, taking a complicated subject and describing it in layman terms. The result is that all our staff are fully training and confident in their roles”. Paula George, General Manager Neubourg Pharma.

One special case that Essjay Solutions worked on was for re-imbursement for a drug tariff. Neubourg Pharma were initially turned down as the price was too high. Essjay Solutions worked on a case and an economic argument and developed a dossier which eventually lead to re-imbursement.

“I have no doubt that the dossier that Essjay Solutions articulately wrote helped us get the re-imbursement we deserved”.

A one-stop-shop

“We don’t need to hear from Essjay Solutions every day, we’re safe in the knowledge that we’re protected. Essjay Solutions are our one-stop-shop for all our pharmacovigilance needs. We don’t need to go anywhere else and our lives are easier because of Essjay Solutions.”