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"The Aclairo® Advantage" is our experienced based approach to providing superior strategic, scientific, and regulatory consulting services. Our approach to drug, biologic, and device development has proven itself to be our greatest asset in helping our clients to streamline their development efforts, and reduce both development time and associated costs. Using the "Aclairo® Advantage" we have accomplished the following:
- Planned and implemented IND strategies for successful submissions of drugs and biologics
- Strategically place products in the appropriate FDA Center to speed development of drugs, biologics, and devices
- Successfully authored and submitted scientific justifications and explanations to move drugs from clinical holds and to justify specific Phase IV commitment preclinical testing rather than pre-approval testing
- Reviewed literature and minimized the testing submission for 505(b)2 applications
- Successfully identified, placed, and monitored nonclinical studies and thus ensured high quality results
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