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PRECLINICAL EVALUATION AND REGULATORY
DOCUMENTS
Entering a new clinical development phase or preparing an application for marketing
authorization of a medicinal product requires a full and critical documentation of
conducted studies and an integrated safety assessment of all available preclinical
data. In addition, such an evaluation is important for the update of the development
plan.
By asking ADMERITOX to prepare the preclinical parts of regulatory documents
or to perform the integrated safety assessment of a product, YOU as the client
may expect:
- an outline of the table of contents
and the order of discussion of the conducted studies
- a well-structured and complete
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 study program and potential issues in the results
- recommendations on how to address
the weak or missing elements by means of e.g. a literature search, a scientific position
paper or an expert opinion
- additional evaluations of the
interrelationships between preclinical and clinical or chemical/pharmaceutical data,
if applicable and needed
- advice and assistance in the
preparation of briefing packages for meetings with regulatory authorities
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