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Welcome to our Internet site
CATS Consultants offers consulting services to the
pharmaceutical/biotech industry, as well as to the chemical industry
and the cosmetics industry,
mainly in the area of regulatory affairs and safety assessments.
For the
pharmaceutical/biotech industry we offer the following services:
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Developing a
worldwide regulatory strategy. This takes into account what data package is
necessary to satisfy the different regulatory authorities, and the choice of
the regulatory procedures (Centralised Procedure or Decentralised Procedure) in the European Union. The proposed strategy is reflected in a
regulatory plan
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Scientific and
Regulatory Advice meetings with Health Authorities
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Applications for
clinical trial approval
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Applications to
obtain designation as an Orphan Medicinal Product from the EMEA
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Preparation of
the non-clinical overview and non-clinical summaries of the Common Technical
Document
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Marketing
Authorisation Applications in the European Union according to the Centralised
Procedure
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Type I and Type
II Variations
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Preparation and
review of Product Information (SmPC, Package Leaflet and Labelling)
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)
- Advice on risk management strategies
- Contracting,
monitoring and evaluation of toxicological studies according to the
requirements of the competent authorities
- Preparation
of dossiers on High Production Volume Chemicals in compliance with the
requirements of the OECD SIDS Programme
For
the cosmetics industry we offer the following service:
- Performing safety
evaluations on cosmetic ingredients and finished products
- Services for the
preparation of registration dossiers under REACH
- Advice relating to the
Globally Harmonised System of Classification and Labelling (GHS)
- Contracting,
monitoring and evaluation of toxicological studies according to the
requirements of the competent authorities
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CATS
Consultants GmbH