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PRECLINICAL EVALUATION AND
REGULATORY DOCUMENTS
Entering a new clinical development
phase or preparing an application for marketing authorization of your product requires
a full and critical documentation of conducted studies and an integral safety evaluation
of all available preclinical data. In addition, such an evaluation is important for
the update of your preclinical development strategy.
By asking ADMERITOX to perform the regulatory documentation of your preclinical
studies or the integral safety evaluation of your product, YOU will receive:
- an outline of the table of contents
and the order of discussion of the conducted studies;
- a well-structured and complete
preclinical regulatory document, in compliance with your writing rules and regulatory
format requirements (Common Technical Document) and with fully documented quality
control;
- a thorough and critical analysis
of possible gaps in the preclinical study program and potential issues in the study
results;
- recommendations on how to address
the weak or missing elements by means of a literature search, a scientific position
paper or an expert opinion;
- additional evaluations of the
interrelationships between the preclinical data and clinical or chemical/pharmaceutical
data, if applicable and needed.
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