What is the Regulatory Cost Optimizer?

The Regulatory Cost Optimizer is a webbased application to calculate and optimize the costs of pharmaceutical drug registrations in European countries. Based on information on current agency fees and local manpower rates it delivers an estimate of the total costs of drug registration projects in each European country.

To whom is it useful?

Pharmaceutical or medical organisations who wish to register or renew registrations of pharmaceutical drugs in European countries.

How can I access the Regulatory Cost Optimizer?

After registering as a user (the registration is for free) you can select from our license options.

How can I buy a license and how much does it cost?

After the free registration, a free 1-month trial period is offered. A license can be purchased from the following license options.

Can i try the Regulatory Cost Optimizer Europe before buying a license?

Yes. For each new user we offer a free trial period of one month with full access to the European Drug Agency database and unlimited cost calculations.

Do I need to install anything to use the Regulatory Cost Optimizer?

No. The Regulatory Cost Optimizer is a webbased application and can be used with an internet browser on PC, notebook, tablet and cellphone.

What is the European agencies database?

The European agencies database lists the drug registration agencies of each European country including their current registration fees. Your regulatory cost calculation will be based on the current agency fees and manpower costs of the target country/ies.

How are the manpower costs calculated?

The manpower costs are based on officially published EU local minimum labor rates multiplied by 3. A factor of 3 is considered to represent a reasonable cost for employing manpower or outsourcing the task in the pharmaceutical industry.

How are the calculations made?

  1. Select a regulatory activity, type and procedure
  2. Select your target country/ies (national, RMS, CMS)
  3. Enter your estimated working hours (optional)
  4. Based on agency fees and local manpower rates we will calculate the total costs of your project

How often do we update our databases?

Our databases are updated regularly to reflect up to date information published on the official agencies webpages.