Previous Projects

CATS Consultants GmbH

Saarburgstrasse 31

D-82166 Gräfelfing

Tel: +49.89.85466868

Fax: +49.89.85852637

Geschäftsführer der CATS Consultants GmbH: Dr. Claudia Fruijtier-Pölloth und Adrianus Fruijtier

Registergericht: Amtsgericht München, Registernummer: HRB 152616

Umsatzsteuernummer-Identifikationsnummer gemäss § 27a Umsatzsteuergesetz: DE236214780

Previous Human Health projects:

External expert to the European Commission on PFOS
External expert to the European Commission on the Technical Guidance Document
Peer review of more than 30 submissions for the OECD High-Production Volume Chemicals Programme
Safety evaluations of more than 50 cosmetics, including oral care products
Monitoring of more than 500 toxicological studies
Drawing up a risk-assessment methodology for ingredients of household products

Previous Regulatory Affairs projects:

Developing a worldwide regulatory strategy. We have done this for several compounds
Scientific and Regulatory Advice meetings with Health Authorities. We have extensive experience with the EMEA, but have also arranged and participated in meetings with other Health Authorities, such as the FDA (End-of-Phase II meetings, Advisory Committee Meetings), BfArM (German Regulatory Authority), and the MPA (Swedish Regulatory Authority)
Applications for clinical trial approval in several countries within the European Union
Applications to obtain designation as an Orphan Medicinal Product from the EMEA
Marketing Authorisation Applications in the European Union. We have co-ordinated the procedures for 15 Centrally Authorised medicinal products. In addition we have some experience with the Mutual Recognition Procedure
Type I and Type II Variations. We have handled over 20 Variation Procedures
Electronic submissions
Preparation and review of Product Information (SmPC, Package Leaflet and Labelling). A major contribution to guidance documents in this area has been made as a member of the Quality Review of Documents and Product Information Quality groups at the EMEA