QData Intelligence
Scientific, software and regulatory support for life-sciences programmes
We help MedTech, digital health, biopharma and research organisations connect biostatistics, clinical methodology, medical software engineering and regulatory documentation — so decisions stay defensible as programmes move toward EU and US expectations.
Expertise
Three connected capability groups — not a generic software shop, not a mega-CRO.
Science
Biostatistics and clinical trial / study design support for evidence that must withstand scrutiny.
Software
Medical and digital health software engineering in regulated contexts — including SaMD support.
Regulatory
Documentation and interaction support related to FDA, EMA and applicable procedures.
Who we help
Organisations we support across industry, healthcare and research.
Experience
Many engagements remain confidential. See anonymised selected work for how we describe outcomes without over-claiming regulator decisions.
See selected workHow we work
Early alignment of methodology, data, software intended use and regulatory documentation reduces avoidable late-stage risk. We do not guarantee regulator decisions, certification outcomes or study results.
Read our methodology →Trust
We are not a regulator, notified body, certification body or clinic. Public contact channels are not for PHI or confidential regulatory packs.
Quality, security & trust →Ready to discuss a programme?
Tell us about your organisation and the type of support you need. Do not send PHI or confidential regulatory packs through the public form.