Services and Expertise include:
- Development, implementation of global regulatory strategies and proactive engagement with Regulators.
- Leadership and mentoring of regulatory and quality professionals
- Development and authoring of Chemistry, Manufacturing and Controls (CMC) sections of clinical trial dossiers (IND, IMPD, CTX) and marketing authorizations (BLA/MAA) encompassing regenerative medicine, combination products and biologics
- Critical review and editing of clinical and non-clinical protocols, reports and briefing documents
- Identifying approaches for efficient process and translational development; moving concepts for medical interventions from research to GMP and ultimately to the clinic
- Establishing expectations for compliance with Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP) and Good Tissue Practices (GTP) at all stages of product development
- Active contributor on scientific and technical due diligence exercises
- Advising on regulatory compliance audits and assessments