Selected work
We have collaborated with more than 40 organisations. Many engagements cannot be named publicly because of contractual confidentiality, NDA terms or our publication policy — so we publish anonymised summaries only, without logos.
Published examples
Detailed anonymised cases (T2). Each page states role and evidence-bound outcomes.
FDA regulatory writing — global pharmaceutical company
Regulatory plan development for a global pharmaceutical engagement. The client submitted the completed plan, which FDA formally approved.
Clinical trial documentation — biopharmaceutical company
Clinical documentation and plan support for a biopharmaceutical engagement, resulting in a client-submitted plan that FDA formally approved.
Ophthalmology medical devices — FDA plan & US marketing authorization
Regulatory planning and authorised FDA communication support for an ophthalmology-device engagement. FDA formally approved the client-submitted plan, and the client’s devices subsequently received U.S. FDA marketing authorization.
Digital health software — clinical operations
Software engineering and documentation inputs for a healthcare / clinical-ops programme.
Research methodology — academic collaboration
Study design and biostatistics collaboration; institution retains scientific and ethics ownership.
Further collaborations (names withheld)
Beyond the cases above, additional work remains unpublished by name for contractual or legal confidentiality reasons. The list below is sector-level only — organisations are not named here.
- Global biopharma / pharmaceutical — FDA-oriented regulatory writing and plan support
- Life-sciences regulatory support — documentation and pathway framing for US-oriented programmes
- MedTech / ophthalmology devices — FDA plan, authorised agency communication and subsequent U.S. FDA marketing authorization (client manufacturer of record)
- Hospital / clinical IT — software and documentation support in clinical-operations contexts
- Digital health products — application and platform engineering near regulated software expectations
- Universities and research institutes — study design and biostatistics collaboration (institution retains ownership)
- Clinical research / CRO tooling — eCRF/EDC and related software collaboration as scoped
- Postgraduate medical education — scientific / educational programme support
- UK life-sciences / public-sector adjacent — programme and documentation support as scoped
Aggregate experience: About (~20 years; 40+ organisations). Naming a specific organisation on this site requires a separate publication checklist.
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