Scientific and regulatory development
Development plan, preclinical and clinical strategy, CMC, quality, CDMOs, regulatory roadmap and technical gates.
Senior advisory that sequences the critical decisions — scientific, legal, commercial and financial — that turn a technology into a company an investor can underwrite.
Projects and companies across pharma, biotech, clinical research, medical nutrition and digital health — teams that need scientific judgement, market sense and the ability to execute.
No plan, no legal structure, and a story that does not survive three questions from an investor. A biotech is not built on good science alone. It is built on decisions taken in the right order.
Promising scientific data, but no clear development plan.
Science, regulation, market and funding pulling in different directions.
No legal structure for the spin-off, the founders, the IP or the contracts.
Financial projections built because a spreadsheet asked for them.
Roadmaps with no gates, no ranked risks and no owners.
A publication is not a company. A patent is not a round.
We structure the project across connected fronts. A bad legal decision hits the funding; a bad market assumption hits the development plan. Nothing here is independent.
Development plan, preclinical and clinical strategy, CMC, quality, CDMOs, regulatory roadmap and technical gates.
Spin-offs, shareholder agreements, intellectual property, contracts, licensing, tech transfer and compliance.
Feasibility, market, competition, business plan, financial model, funding strategy and investor narrative.
Scientific video, event broadcasting, web design and training material to explain and position the project.
Three senior disciplines sequence the decisions that make a biotech investable — from the science and its protection to the business case the investor signs.
From the promising experiment to the asset roadmap: target product profile, evidence strategy, regulatory route and CMC, sequenced from preclinical to first dose in humans.
We protect the asset and structure the company: freedom to operate, patents, corporate structure, licensing, and the regulatory and data compliance that gets due-diligenced.
We build the case that raises capital: market and competition, business model, financial plan, funding strategy and investor narrative — from the public grant to the Series A.
We do not sell blocks of hours. Every program has an objective, a scope and a set of deliverables — so you know what you get and when.
A fast read of the project: scientific, legal, market and funding maturity, with the critical decisions ranked.
The development and business plan sequenced gate by gate: milestones, risks, costs and owners, ready to execute.
The legal structure that makes the technology fundable: company, shareholder agreement, IP and key contracts.
The case an investor underwrites: business plan, financial model, investor memo, pitch deck and data room.
An independent report on the maturity and investability of the asset, with a roadmap to close the gaps.
Part-time project direction: milestone, runway and risk tracking, with periodic reporting for the team and its investors.
First we think. Then we structure. Then we execute. We leave the magic to LinkedIn.
We do not deliver general recommendations. We deliver the structure to decide and move.
Building a biotech takes science, regulation, law, business, funding, market and execution. That is why the team is put together the way it is.
Chief scientific officer. Over 25 years in pharma and biotech: drug development, CMC and scientific strategy.
Lawyer: contracts, corporate, R&D, pharmaceutical and administrative law, biotech legal support.
Business development, strategy, market and access. Customer strategy in pharma and biotech.
Digital training, audiovisual production and scientific communication.
Tell us where the project stands. Book a call or write to us through the form and we will come back with the next steps.
Tell us where the project stands and we will help you work out what it needs to move: development, legal, market, funding, or all of the above.