Working with JensonR+: A Case Study

JensonR+ is a trusted regulatory affairs consultant and partner. This case study outlines the support that we offered to one of our valued clients.

The Challenge

Small virtual company with a novel pain relief product that uses a well-established pain relief ingredient.
The client required a development plan to present to future investors.

The Solution

An expert team with EMA scientific advice experience was assigned to collaborate with the client.

Coordinated scientific advice procedure including coaching the client on Scientific Advice Meeting (SAM) best practice.

Facilitated discussions with PK, clinical and in silico-modelling experts.

Reviewed the available development work and identified key areas for discussion with EMA.

Prepared a coherent scientific advice package for submission to EMA.

Benefits

The client gained valuable insight into the development requirements for the product, enabling the preparation of a robust development plan with outline costs for investors.

Detailed advice from Scientific Advice Meeting (SAM)

Expert analysis of minutes provided to the client to assist preparation of the development plan.

Our Regulatory Consultancy team of experts can guide your regulatory affairs strategy to help you get the most from your products in the best possible timeframe.
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