Experience sets the pace…

Aclairo’s experience as FDA supervisors, reviewers, and industry strategists has forged a unique comprehension of the product-specific complexities of pharmaceutical development. The Aclairo advantage is our experience-based approach to providing strategic, scientific and regulatory services. This has proven to be our greatest asset in focusing and streamlining our clients’ development efforts, reducing both time and costs.

A wide range of issues can delay a product’s development program…

Aclairo believes that there is no substitute for rigorous science and regulatory strategy in clarifying the most efficient pathway for products through the development course. Our mastery of these complex issues allows us to readily identify and facilitate the resolution required to move a drug’s development forward.

Not every client’s needs are the same…

Aclairo consultants are well-versed in a broad range of pharmaceutical development areas resulting in an ability to customize our services to suit each client’s individual needs. Aclairo specializes in product development programs and strategies, data interpretation, gap analysis, and design and 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, investigator brochures, expert reports and FDA response documents.