Regulatory Cost Optimizer Europe

Salmitics

Inspiration

As a Regulatory Affairs Consultant working in the life science sector for many years I learned how vital it is to have the right IT solutions at hand when it comes to the complex tasks surrounding a drug or medical device registration.

What it does

The Regulatory Cost Optimizer is a web-based application calculating the total costs of pharmaceutical drug registrations in European countries. Based on up-to-date information on agency fees and manpower rates of each (European) country, it supports pharmaceutical companies calculating their registration costs, including the required manpower, at all stages of their product lifecycle. This allows costs optimization based on a few clicks.

How I built it

The Regulatory Cost Optimizer is a web-based application using PHP.

Challenges I ran into

The main challenge is to keep the agency fees up to date and the fact that there are many sub-categories for drug registration which are not completely harmonized across Europe.

Accomplishments that I'm proud of

The Regulatory Cost Optimizer allows costs optimization based on a few clicks. This is especially useful in situations like COVID-19 where there is a high pressure to bring cures to the market while the user(s) may not be form the regulatory field. Academics and start-ups researching under pressure could have this information at their fingertips based on a few clicks which could help them optimize their registration strategy.

What I learned

I learned that the industry would greatly benefit from such and other tools which help professionals speed up their project timelines and bring drugs and vaccines to the market faster.

What's next for Regulatory Cost Optimizer Europe

The next step for Regulatory Cost Optimizer Europe is to fine tune the costs and include country specific details to make the tool even more useful to the end users.