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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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