Innovation and strategy

Start-ups, university and research teams, hospitals and established companies. It suits anyone who needs a clear path from an idea to a product that is approved and backed by evidence.

This is where start-ups often lose the most time. Teams build the product and plan for approval at the same time, but the two plans do not talk to each other. We bring regulatory planning in from the start. We help you design validation studies that give evidence CDSCO will accept. We help you build your technical file (the documents that describe your product) as you build the product. This avoids redesigns when gaps turn up late. You can work with us by milestone, by project or a mix of both. You get senior regulatory help without hiring a full-time team.

Yes. Research rarely stalls because the science is weak. It stalls because the path from a paper to a product needs regulatory, practical and business work. We work with universities, research hospitals and technology transfer offices. We map the route to approval early. We find what extra evidence CDSCO will need beyond your research data. Then we build a plan from proof of concept to a dossier ready to file. We have supported projects in diagnostics, medical devices, software, nutraceuticals and medicines.

Research studies answer a science question. Regulatory studies show that a product is safe and works. They must meet a set standard, in a defined group of patients, with outcomes chosen before the study starts. We do a regulatory gap assessment on your data. It shows what you have, what it proves, where the gaps are and the quickest way to close them. Often your data can be reused or topped up with a small bridging study, instead of a whole new clinical programme.

Before. Ideally before you design the study that will give those results. The most costly mistake is a study that answers the science question well but not the regulatory one. A little regulatory input at the design stage helps. It covers which patients to include, which outcomes to measure, how many patients you need, how to frame the ethics application and how to collect data. Then one study serves both purposes. If you already have results, we will work with what you have. But the earlier we talk, the more options you have.

Yes. We review the science, how far the prototype has come, the patent and ownership details you share with us, and the need it meets. We also check its regulatory class and the gaps in its evidence. Then we set out practical next steps.

Most start with a short strategy workshop and a gap assessment. After that you choose how to continue: milestone by milestone, as a set project, or a mix of both.

A roadmap in order of priority. It covers the science work, regulatory decisions, evidence to collect, partners, key risks, what depends on what, and the next actions we recommend.

We help with the technical story, the development roadmap, answers to due diligence questions and milestone plans. We do not give financial advice, and we do not raise investment for you.