Biopharma Consulting

I offer specialized consulting for biopharmaceutical companies and investors. Core services include regulatory medical writing (protocols, clinical study reports, BLA/NDA submissions, briefing documents, and agency responses), regulatory submission planning and execution, and AI tool selection and onboarding. I also provide strategic advisory services including needs assessments, gap analyses, organizational build-out, and fractional or interim functional leadership across Medical Writing, Clinical Operations, Medical Affairs, and Medical Communications.

For venture capital and private equity firms, I offer industry-specific due diligence support and acquisition evaluations — providing expert assessment based on my ~30 years in the biopharmaceutical industry to help you invest and transact with confidence.

Every engagement starts with understanding your goals. For operating companies, I tailor my approach based on whether you need hands-on execution, team leadership, or interim functional coverage. For investor clients, I structure engagements around the specific questions driving your decision — such as functional capabilities or transaction readiness — and deliver clear, actionable assessments on your timeline. Across all engagements, I bring a disciplined focus on quality and execution, with a track record of delivering in time-sensitive environments.

Pricing is customized based on the scope, complexity, and duration of each engagement. I offer flexible models — including hourly and retainer arrangements — to suit organizations ranging from emerging biotechs to large pharma and investment firms. Please reach out to discuss your needs and we can identify the right structure together.

Yes. I have a strong track record with a wide range of clients including Takeda, Shire, Alexion, among others. I've led teams through five BLA/NDA/NDS submissions on or ahead of schedule, supported drug approvals across FDA, Health Canada, and Japanese health authorities, and advised on M&A and corporate transactions. References are available upon request.