STRATEGIC CONSULTING FOR DRUG AND BIOLOGIC DEVELOPMENT
Regulatory Consulting for Expediting Drug Development
Jeff draws from a wealth of strategic experience in novel drug development to provide in depth and executable regulatory strategies that are focused on speed to market while ensuring scientific rigor and regulatory compliance.
Strategy
Development of clear and executable regulatory strategies for new or ongoing drug development programs. Includes planning across all stages, seeking alignment with regulators, and addressing regulatory requirements and agency feedback.
Execution
Hands-on support for the planning, strategy, review, and preparation of core regulatory documents, from INDs/CTAs to NDAs/BLAs/MAAs. Includes but not limited to regulatory agency responses, special designations applications and briefing books
Due Diligence
Regulatory due diligence support for in-licensing, partnering, or acquisition decisions. Evaluate existing regulatory plan, documentation, and risk to inform asset valuation for transaction decision making. Develop new strategic plans for asset.
ABOUT JEFF
What Jeff can help with…
…all aspects of drug development from early phase first in human to post-approval line extension in novel biologics and novel or reformulated small molecule drugs.
Asset due diligence
Overall drug development strategy
Regulatory document review, from IND to NDA/BLA
Regulatory Department planning and implementation
30 Years of Drug Development Experience
