FAQ

Learn more about RegIntA

Which areas does the Daedalus database service cover?

The Daedalus service is aimed at all medical device manufacturers and the pharmaceutical industry who want to avoid time-consuming and costly internal research on national legal requirements, but still want to have the most up-to-date information at hand.  

The industry can choose from a variety of areas throughout the life cycle of a drug or medical device, such as product registration or safety notifications for clinical trials or after product approval.

How does the Daedalus database service work?

First you sign the basic contract. Then you choose

  • for which countries you need information,
  • You select the package for each selected country and
  • determined the number of accesses for the Daedalus service.

With your password you log in to the Daedalus online portal via the RegIntA website.

Here you will find all contractually agreed country-specific regulatory intelligence based on national regulations.

How does the package system work within Daedalus? 

The regulatory information provided in Daedalus is offered in three kind of packages:

  • The basic package provides you with an up-to-date regulatory summary of the essential regulatory requirements
  • The premium package gives you a details insight into the regulatory requirements.
  • The premium plus package: This package provides full service by providing all details and instructions to enable you to meet your regulatory obligations.

You are free to choose the package that fits your need for every single country.

What information can I expect?

The offered information depends on the chosen area and country package.

Details provided include, but are not limited to, legal basis, definitions, language requirements, country specific forms or ways of submission. 

You can easily understand what steps are required to meet your regulatory compliance obligation. Forms or instructions, necessary to be submitted, can be directly downloaded.

Please see below an example for medical device registrations:

How will I know that booked regulatory intelligence has changed?

An essential  success factor for the Daedalus service is to regular check the data’s up-to-dateness. Identified changes are reviewed in a timely manner. If the change has an impact on the booked intelligence, a revised version is promptly uploaded to Daedalus and you are informed about the newly uploaded version.

Changes in the regulatory intelligence are highlighted within Daedalus and listed in the version history. Audit trails in accordance with legal requirements are available to our clients for audits and inspections on request.

What service does the Daedalus electronic client management system offer?

Daedalus’ electronic client management system offers you the greatest possible flexibility in the contract designs by adapting orders individually to your projects:
Within the database you can request new work orders or adjust your current work orders according to the terms of the contract. This allows you to extend the booking periods for countries or accesses as you wish, to upgrade or downgrade country packages or to make requests for new countries and accesses. The RegIntA team will check the feasibility and contact you promptly.

The monthly invoices, the basic contract and all work orders that supplement the basic contract for countries and accesses are available electronically in the system.

Will I require to book the regulatory intelligence for each employee?

No. Accesses to Daedalus are booked separately from the country orders. If requested, all employees with access can view the booked regulatory intelligence.

What are the costs for Daedalus’s database service?

The Daedalus service is charged with a monthly flat rate for the booked countries and accesses.

The pricing of service depends on the selected area, the country’s packages, the number of contracted countries and the number of accesses. 

In general, the minimum booking period for a country is one year. Terms of less than one year are negotiable.

Please contact us so that we can prepare an individual proposal for you.

I need further information that is not included in Daedalus’ database service. Can you help?

Sure, we are happy to support you. Further assistance and information that is outside the Daedalus database scope can be contracted separately under a consulting contract.

Please contact us so that we can find out how we can support you.

Address

Company

Legal

RegIntA GmbH

Nieder-Rußbacher-Str. 1

63674 Altenstadt

Germany

Executive Director:

Katrin Rosen

Ust.-ID: DE 317189811

HRB 8759

Amtsgericht Friedberg