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Design and support of nonclinical and early phase clinical development programs requires an innovative and integrative strategy that is relevant to the intended clinical indication. The Aclairo® consultancy draws from in-depth scientific, FDA, and industry experience to provide benchmark strategies and regulatory support to help you meet this challenge.
Scientific and Strategic Nonclinical Development:
- Participation on Expert Panels
- Due diligence for acquisitions
- Nonclinical program study design and management
- Nonclinical study placement and monitoring services
- Review and interpretation of nonclinical studies
- Critical evaluation of nonclinical testing facilities
- Nonclinical safety assessments
- Review and integration of the scientific literature
- Strategic regulatory development plans
- Clinical dose selection based on nonclinical data
- Preparation of manuscripts
Regulatory Document Preparation and Review:
- Nonclinical report and summary preparations
- Preparation of regulatory applications (Pre-INDs, INDs, NDAs, IDEs, 510K, CTDs)
- Preparation of regulatory documents: investigator's brochures, periodic reports, application summaries, expert reports, package inserts, patient information leaflets, labels, and product monographs
- "Mock FDA Reviews" of draft submissions, identifying areas of vulnerability
Regulatory Meeting and Communication Support:
- Meeting preparation (briefing documents, rehearsals), and representation at FDA-industry meetings (Pre-IND; End of Phase I and II, Advisory Committee, Carcinogenicity Assessment Committee)
- FDA responses and correspondence
- Regulatory review of promotional material
- Coordinating Expert Panel Panel Meetings
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