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CATS Consultants offers consulting services to the pharmaceutical/biotech industry, medical devices industry, food industry as well as to the cosmetics industry and the chemical industry, mainly in the area of regulatory affairs and safety assessments.
For the pharmaceutical/biotech industry we offer the following services:
Developing a worldwide regulatory strategy. This takes into account what data package is necessary to satisfy the different regulatory authorities. The proposed strategy is reflected in a regulatory plan
Briefing meetings with the Innovation Task Force from the European Medicines Agency
Scientific and Regulatory Advice meetings with Health Authorities
Applications for clinical trial approval
Applications to obtain designation as an Orphan Medicinal Product in the EU
Applications for Paediatric Investigation Plans (PIP), PIP deferrals and waivers in the EU
Eligibility requests for the priority medicines (PRIME) scheme of the European Medicines Agency
Preparation of the non-clinical overview and non-clinical summaries of the Common Technical Document
Marketing Authorisation Applications in the EU
Type I and Type II Variations
Preparation and review of Product Information (SmPC, Package Leaflet and Labelling)
Derivation of permitted daily exposure levels (PDEs)
Preparation of environmental risk assessments
For the medical devices industry we offer:
Preparation of Biological Safety Assessments
For the food industry we offer:
Preparation of safety evaluations of food ingredients, additives and flavouring substances
For the cosmetics industry we offer the following services:
Safety assessments and cosmetic product safety reports
Services for the preparation of registration dossiers under REACH
Contracting, monitoring and evaluation of safety and efficacy studies according to the requirements of the competent authorities
For the chemical industry we offer the following services:
Human Health and Environmental Risk Assessments on chemicals according to internationally accepted standards
Services for the preparation of registration dossiers under REACH
Advice relating to the Globally Harmonised System of Classification and Labelling (GHS) and the European CLP regulation
Advice on risk management strategies
Contracting, monitoring and evaluation of toxicological studies according to the requirements of the competent authorities
Preparation of dossiers in compliance with the requirements of the OECD Cooperative Chemicals Assessment Programme
Who we are
Adriaan Fruijtier
Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands. Until March 2004 he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA.
Claudia Fruijtier-Poelloth
Claudia Fruijtier Poelloth has been an independent toxicology consultant since 2001. She has graduated as a M.D. (Dr. med.) and obtained an M.Sc. degree in Chemistry at the University of Ulm, Germany. In addition, she is a Certified Toxicologist (German Society of Pharmacology and Toxicology), registered in the European Registry of Toxicologists.
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