QUALITY 

Our key priority

RegIntA has developed and implemented a Quality Management System consistent with the general principles of the ISO 9000 Standards, EMA's GVP and ICH E6 (R2). 

We perform quality checks at every stage of the development of regulatory intelligence before data is uploaded to Daedalus®

All revisions within Daedalus® are tracked in a version and audit-proof manner.

All RegIntA applications, like the Daedalus® database, are subject to validation.

RegIntA recognizes that achieving the required quality of processes and services provided is intrinsically linked with the availability of a sufficient number of competent and appropriately qualified and trained staff. 

For all staff members ongoing and topic related trainings are conducted regularly.

RegIntA’ s Quality Policy

RegIntA is committed to the delivery of excellent service that meets and exceeds our client's needs and expectations and complies with relevant national and international regulations and other quality requirements.

To meet this commitment, RegIntA ensures the highest priority is placed on the quality of the provided data and service. A Quality Management System, policies and procedures have been implemented that define RegIntA's quality standards and working processes and are consistent with the general principles of ISO 9001-2015, GVP Modules and ICH Guidelines, such as the Good Clinical Practice. 

Beginning with a clear definition of overall objectives, we strive to consistently comply with national and international regulatory reporting requirements and meet or exceed clients’ needs and expectations. We adhere to all applicable standards and client specific requirements and endeavor to provide processes that ensure we achieve this in order to build a robust and world-class business. 

Client needs and expectations are paramount and represent the highest priority within our business. Our obligation is to proactively search for dialogue and constructive exchange with the client. Requests are expeditiously addressed.

Whenever possible clients' needs andexpectations are converted into objectives and implemented to improve the clients' satisfaction. Our performance is monitored and regularly reviewed to ensure our standards of conduct meet our objectives. RegIntA's responsible person for Quality Assurance is in charge for reporting regularly to RegIntA's executive team on the system's implementation, status and effectiveness.

All RegIntA team members are responsible for the quality of their work. RegIntA ensures that all RegIntA team members have the appropriate education, training, skills and experience to carry out their work competently, in accordance with applicable regulations and RegIntA's quality standards.

RegIntA aims to continuously improve the provided service using a risk-based approach at each stage of development across the entire quality life circle.

While we endeavor to offer a service that we can be proud of, we have to recognize that our standards are not always achievable. We are committed to investigate the reasons. Service weaknesses are used to drive our continual improvement system. 

RegIntA is committed making the quality policy an integral aspect of our practical, everyday work in order to achieve our aims of long-term success, sustained improvements and long-lasting client relations.

Address

RegIntA GmbH

Nieder-Rußbacher-Str. 1

63674 Altenstadt

Germany

Company

Executive Director:

Katrin Rosen

Ust.-ID: DE 317189811

HRB 8759

Amtsgericht Friedberg

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