Regulatory Consultation
Industry Services
CERICOS
Cericos is a private consultancy company established in 2008 to provide broad regulatory expertise on risk assessment, information requirements, individual tests (NAMs and OECD TGs) and testing strategies.
The expertise covers drug development from discovery until the marketing approval application but also REACH and the other chemical legislations. The expertise is gained from education and many years´ practical work in these areas.
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The expertise also covers development and validation of New Approach Methods and strategies.
Increase probability of success of your drug candidate in different phases of development process.
The probability of success of drug development can be increased by ensuring the most viable (efficient, safe and with desired pharmacokinetic profile) candidate to enter the development phase. Human cell based New Approach Methodologies have high potential to improve probability of success and shorten the development time.
Develop NAMs valid for research and regulatory use.
Future view: The whole-body risk assessment is performed by using regulatory relevant and human cell based in vitro models and with other relevant non-animal tools combined with mathematical programs.
SERVICES
We offer for drug developers
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Designing a drug development plan covering the individual tests according to the regulatory requirements taking into consideration mechanism of action of the molecule and TPP.
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Writing individual study protocols related to safety.
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For individual studies: Identifying the most suitable CRO, negotiating details in the study protocol, monitoring the study, and ensuring the adequate reporting of the study.
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Writing Non-clinical Confidential Information and Investigator´s brochures.
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Performing due diligences for non-clinical documentations.
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Regulatory processes and requirements (EU and US).
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We offer for test and testing strategy developers
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Knowledge how to develop NAMs adequate for regulatory use.
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Knowledge how to validate methods.
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Knowledge on Good Laboratory Practice (GLP).
Contact information
Tuula Heinonen
Professor, Ph.D., European Registered Toxicologist, CEO, founder and owner of Cericos
Email: cericos@gmail.com
Tel. +358 40 903 0086
