Regulatory technology

Regulatory technology work by D. Klincharski, connecting specialist knowledge with software that keeps sources and evidence visible. RafiHive supports EU pharma regulatory affairs; WardBee by ScanComb connects cloud and repository evidence to compliance reviews. The articles explore the decisions behind both.

About D. Klincharski

Builds / Tools / Labs

Projects to explore.

01 Product RafiHiveSupport EU pharma research, dossier gap checks, and packaging reviews with cited evidence and qualified RA oversight. Explore project 02 Product ScanCombUse WardBee by ScanComb to check AWS and repository evidence against framework controls and prepare compliance reviews. Explore project

Articles / Experiments

Notes from the work.

01 Oct 07, 2026 A cybersecurity conference cold-called me like an old friend. That's the problem.A legit security event called me with my mobile, private email and work email, which I never gave them. What GDPR says, and what to do when it happens to you. Journal · 7 min 02 Sep 29, 2026 Start compliant: a Terraform Fargate baseline that passes the scanner on day oneHow the open-source Terraform ECS Fargate starter now ships the controls WardBee by ScanComb checks for, so new services begin with evidence instead of a remediation backlog. Technical blog · 6 min 03 Sep 23, 2026 NIS2 Supplier Check: Turn Customer Questions into EvidencePrepare for NIS2 supplier questionnaires with technical checks, a 15-question self-assessment and a clear evidence report. Preview ScanComb's approach. Journal · 6 min 04 Sep 18, 2026 The AI boom has entered its compliance phase: what the EU AI Act changes for companiesFor years the AI question inside companies was what models could do. The EU AI Act turns it into something harder: can you prove what your AI systems access, what protects them and who is responsible? Journal · 6 min 05 Sep 17, 2026 Agentic AI in regulatory affairs: how much autonomy is too much?FDA is already deploying agentic AI, while pharma companies are exploring AI agents for regulatory intelligence and authoring. What should an AI agent actually be allowed to do in regulatory affairs? Journal · 10 min 06 Sep 17, 2026 EU AI Act 2026: what it means for AI agents in pharmaceutical regulatory affairsThe EU AI Act now applies across much of Europe while EMA and FDA are defining principles for AI in medicines. What does this mean for AI agents used by pharmaceutical regulatory affairs teams? Journal · 8 min 07 Sep 02, 2026 Why AI gets regulatory affairs wrong when you remove the source documentsLanguage models are excellent at sounding like a regulation and unreliable at being one. Here is what goes wrong when the primary source is out of the loop, and how to keep it in. Journal · 5 min 08 Jul 24, 2026 Why domain expertise belongs in the product loopAI can accelerate regulated work, but useful software begins when domain specialists shape the product itself. Journal · 2 min 09 Jul 22, 2026 ScanComb and WardBee: evidence for cloud compliance in the age of vibe codingWardBee by ScanComb checks cloud and repository evidence against framework controls, exposes gaps, and prepares compliance reviews with human sign-off. Journal · 3 min 10 Jul 21, 2026 What RafiHive is for, and who actually needs itRafiHive supports EU pharma regulatory research, Module 1 gap checks, and packaging and labelling reviews with cited sources and qualified human oversight. Journal · 3 min

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