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PRECLINICAL DEVELOPMENT STRATEGY

Preclinical studies (ADME, safety pharmacology and toxicology) are essential for the development of your product and the regulatory submission of your dossier. For each drug project, a well-conceived preclinical development strategy, focussed on your specific needs, is the indispensable basis of a first-time-right study program. A first-time-right approach results in the timely start of clinical development phases, efficient dossier preparation and an uneventful review by regulatory authorities.

By asking ADMERITOX to work out the preclinical development strategy for your drug project, YOU will get:

  • a preclinical development strategy in compliance with your short-term and long-term project objectives and integrated with your chemical, pharmaceutical, clinical and regulatory strategies;
  • a preclinical development strategy tailored to your existing data and the appropriate regulatory guidelines;
  • a preclinical development strategy with a clear rationale and objectives for the studies envisaged;
  • a preclinical development strategy allowing you to proceed to a satisfactory planning, an accurate budget and a successful control of the potential constraints.