About the Regulatory Cost Optimizer

What is the Regulatory Cost Optimizer?

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.

Who should use it?

Pharmaceutical or medical companies who wish to register or renew already registered drugs in European countries.
The Regulatory Cost Optimizer will calculate your total registration costs, including the costs of required manpower – during all stages of your regulatory projects.

How can I access the Regulatory Cost Optimizer?

After registering as a new user you will get full access to the European agencies database and will be able to use the cost calculator - for a one month free trial period. When the trial period has expired you will be asked to purchase a licence if you wish to continue using the Regulatory Cost Optimizer.

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

After your free trial period has expired you will have the option to buy a one year / one user licence, for an annual fee of € 120. This licence can be ordered online and the payment options are: VISA, Mastercard, Diner's Club and Paypal.

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

No. The Regulatory Cost Optimizer is a webbased application and works on all popular browsers, such as Firefox, Google Chrome, Microsoft Edge, Opera, Apple Safari and more.

On which devices can I make calculations?

The Regulatory Cost Optimizer works on any device that is connected to the internet, such as desktop computers, notebooks, tablets and mobile phones.

What is the European agencies database?

The European agencies database lists the drug and device 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 does the calculation work?

  1. You select your regulatory activity
    Select a regulatory activity (MAA, renewal, variations,..), type (full-, generic application,..) and procedure (national, MRP, DCP, CP).
  2. You select your target country/ies
    Select the target country/ies (national, RMS, CMS) your regulatory project is aiming for.
  3. Your enter working hours
    This is optional: Enter an estimate of manpower hours your project will require. The calculation will be based on current local country rates.
  4. Get calculation
    The Regulatory Cost Optimizer will calculate your total project costs. You may add another calculation to this result, if required.