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Consulting and training
for your clinical development

Regulatory affairs and quality

During the whole development process, we provide support in building the product label and we prepare regulatory submission documents.

We design exposure-response review package for EOP2 (End-Of-Phase 2) meetings with FDA.

We know how to write expert reports and CTD (Common Technical Document). We are also experienced with European mutual recognition and centralized procedures, as well as supporting older national submissions.

We have developed a quality system around our services to ensure that analyses are reproducible and fully documented. Our system includes SOPs and working practices for all study related activities, including computer systems.

We perform quality audits of systems, of clinical study reports and regulatory documents.

We help clients design their quality management system and write their SOPs.

 

Need more information about our regulatory affairs and quality services? Contact us!