FAQ 

Learn more about RegIntA

Which areas does the RegIntA database service cover?

The RegIntA service is aimed at the pharmaceutical and medical device industry who like to benefit from our service and avoid time-consuming and cost intensive internal research and updating of national reporting requirements. 

The industry can choose from a variety of areas throughout the life-cycle of a drug or medical device such as registration requirements, safety reporting requirements for clinical trial or after marketing authorization.

How does the RegIntA database service work?

Our clients log into the RegIntA Online Portal with their password from the RegIntA website.

Here they will find all the contracted country-specific details based on the national regulations. 

All information is clearly structured. Details provided include, but are not limited to, definitions of timelines and events, language requirements, country specific forms or ways of submission. Our clients can easily understand what steps are required to meet their regulatory compliance obligation. Forms or instructions, necessary to be submitted, can be directly downloaded.

How will I know that booked regulatory intelligence has changed?

An essential success factor for the RegIntA service is to regular check the data’s up-to-dateness. Updates are promptly uploaded to the database. Changes in the regulatory intelligence are highlighted and listed in the version history. Audit trails in accordance with legal requirements are available to our clients for audits and inspections on request.

How can I order country specific regulatory intelligence?

Once you have signed the basic contract, you can order the required country-specific information in relation to the requested area via our electronic client management system within the online portal. 

RegIntA’s electronic client management system offers our clients the greatest possible flexibility in the contract designs by adapting orders individually to projects on the basis of a modular system. Each country is booked individually with start and end time. The manager can extend the booking periods at will or make enquiries for new countries and accesses. The RegIntA team checks the feasibility, sends the electronic confirmation promptly or develops alternatives with the client. The basic contract as well as the work orders, which supplement the basic contract for countries and accesses, are available electronically within the system.

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

I require further information that is not included in RegIntA’s database service. Can you help?

Yes, we can. Support and information that is outside the RegIntA database scope can be contracted separately. 

Please contact us so that we can discuss how we can support you.

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

No. 

Accesses are booked separately from the country orders. If requested, all employees with access can view the booked regulatory intelligence.

What are the costs for RegIntA’s database service?

The RegIntA 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 degree of difficulty, the contract term and the number of accesses. Terms of less than one year are negotiable.

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