Biopharma Consulting
Industry advisory · Regulatory writing · Submission planning and execution · AI tool selection and onboarding
Industry advisory · Regulatory writing · Submission planning and execution · AI tool selection and onboarding
Common Questions, Answered
We 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. Strategic advisory services include 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, we 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, we tailor an approach based on whether you need hands-on execution, team leadership, or interim functional coverage. For investor clients, engagements are structured around the specific questions driving your decision — such as functional capabilities or transaction readiness — to deliver clear, actionable assessments on your timeline. Across all engagements, you can expect 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. Flexible models — including hourly and retainer arrangements — are offered 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. References will confirm a strong track record of leading teams through BLA/NDA/NDS submissions on or ahead of schedule, supporting drug approvals across FDA, Health Canada, and Japanese health authorities, individual contributor performance, as well as advising on M&A and corporate transactions. References available upon request.
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Boston, MA
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