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On average bringing a new drug to market take approximately 15 years and cost over half a billion dollars. Our experience as FDA reviewers, team leaders, and industry strategists, has forged a unique comprehension of the product-specific complexities of pharmaceutical development. For our consultants there is no substitute for rigorous science and regulatory strategy in making clear the efficient course for products through the development cycle.
Our mastery of these fundamentals allows us to readily identify and facilitate the resolution of scientific and regulatory issues that can stagnate a product's development program, if left unattended. Aclairo® specializes in product development programs and strategies, data interpretation, and design and the implementation of nonclinical and early phase clinical studies.
In addition, Aclairo® consultants are experienced in supporting the gamut of regulatory document preparations including, final study reports, regulatory applications (INDs, NDAs, BLAs, IDEs, 510K, PMAs, CTDs), investigator brochures, expert reports, and FDA response documents. |
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