Regulatory operations · Evidence traceability
I spent nine years making that happen by hand, across submissions, publishing and promotional review. Now I am building a way to measure whether it actually held.
A claim, the evidence behind it, the exact place that evidence sits, and the annotation recording the link are each written by a different person, in a different system, in different words. So a search for the claim does not find the evidence, even when the relationship is real and correct. Teams close that gap by hand, every cycle. The audit trail is thinnest exactly where digitalisation asks it to carry the most weight, and nobody can say how thin, because there has never been a way to measure it.
Two of these trace cleanly to a source location. The third reads as reasonable and has nothing behind it. Finding that third one, reliably and at scale, is the problem my research addresses.
Promotional copy
Source evidence
Select a claim.
Document preparation, eCTD publishing and lifecycle maintenance, master submission libraries and version control that hold up under inspection.
Change annotation and the review packages built on top of it, so every approval decision has its evidence attached and findable.
Factual and numeric review against post-text sources, citation appropriateness, and discrepancy evidence recorded before promotion.
Built to be audited rather than merely to store files. Veeva Vault PromoMats and RIM, eCTDXPress, ISI Publisher, Lorenz DocuBridge.
Engagements are described by function. Client specifics are available in confidence.
Drag or scroll →
2025 – now
Area 23, IPG Health · freelance, remote
End-to-end submission lifecycle support across global brands, including the promotional workflow of a global immunology biologic: document preparation, QC routing, claims tagging and linking, change annotation, and progression through approval to distribution in Veeva PromoMats and Vault RIM.
2025
McCann Health, London · concurrent engagement
Regulatory operations support across submission packages and promotional review cycles, with quality gatekeeping against client SOPs and agency standards.
2023 – 2024
Novartis Healthcare, Hyderabad
Independent source-data verification of clinical and preclinical summary documents, with full factual and numeric review against post-text sources, citation appropriateness checks, and QC of CSRs, CERs and clinical summaries prior to promotion.
2021 – 2023
Fishawack, Avalere Health, London
Ran MLR electronic review for client committees across more than a hundred messaging approvals, and built the reference libraries and claims matrices those approvals depended on.
2017 – 2021
DXC Technology, Hyderabad
Document-level publishing and QC within the eCTD lifecycle for global pharmaceutical portfolios, including third-party source documents from contract research organisations; ISI Publisher, ISIToolbox and PRISM automation processes.
2015 – 2017
Active Pharma Labs and CARE Hospitals, Hyderabad
Analytical quality control by HPLC, GC and UV spectrophotometry; before that, prescription review, drug-interaction checking and controlled-drug records in hospital pharmacy.
The system recommends. A person decides. The decision is recorded.
ClaimFlow proposes AI-assisted matching of claims to semantically equivalent evidence, where every suggested link goes back to a qualified reviewer with its source location and provenance attached. Developed independently, from the problem above.
Protocols are being prepared for public registration, and I am looking for a UK host institution for the work. Technical specifications are shared under a confidentiality agreement.
Mapping the failure modes in real submission and content workflows, and what they have in common.
Platform-agnostic semantic matching, evaluated against string retrieval rather than asserted to beat it.
Validating the metric on a dataset built from public regulatory sources, so that anyone can reproduce the result.
Confidence thresholds, escalation rules, and audit-ready records of what the system suggested and what the reviewer decided.
From colleagues · LinkedIn recommendations
Omer became an advanced Veeva Vault PromoMats user. He is adept at reference linking and comment annotating in that platform, and he displays strong organizational and communication skills, always making detailed notes for current and upcoming projects.
Omer is the hardest working team member I have ever had the pleasure to manage. When I joined, he had assumed regulatory submission ownership over the entire UK marketing line of business. He is meticulous and holds himself to a very high standard.