connect

Find the writing. Follow the thinking. Write back.

iFeed is a thinking practice in continuation. The substrate is on record — almost a decade of public writing across regulated science, a working bioanalytical foundation, and the methodology documented openly. The way to engage is the same way the writing emerged: read, think, write back.

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The inbox, live. Read · think · write back.

Six recent threads · one is being written right now

This is what engaging with iFeed actually looks like — an open inbox. Six recent threads, each from a real surface of the regulated-life-sciences world: a QA lead, a regulatory-affairs head, a validation engineer, a governance officer, an academic, a CRO operations lead. The first thread is live — being written back this moment. The loop never closes; the response becomes the next thing read.

/ inbox · 6 threads live · just now SENDER SUBJECT · SNIPPET WHEN QA Lead · pharma @anonymised · enterprise M10 + AI in bioanalysis · how do we defend the validation package "...the inspector wants the audit trail to demonstrate human-in-the-loop on every prediction. We've structured the QA review as..." just now typing... Regulatory Affairs · biotech @anonymised · mid-stage QMSR transition · which order do we sequence the controls "...we've inherited a 13485 system but the FDA inspection is in 9 months. Our gap is mostly..." 2h ago replied · awaiting Validation Lead · CRO @anonymised · contract research 9-pillar BMV scope · do we cover incurred-sample reanalysis "...the sponsor asked us to extend the validation scope to ISR but our SOP only covers..." 1d ago replied Governance Officer · MedTech @anonymised · class-IIb device PCCP architecture · review request before submission "...we've drafted the predetermined change control plan but want a second pair of eyes on..." 3d ago scheduled · 30 min Academic · university @anonymised · pharmacy faculty Guest lecture · regulated AI for postgrad QA cohort "...we'd like a one-session intensive on what's changed in 2025–2026 across ICH M10, M11..." 5d ago accepted CRO Operations · Pune @anonymised · BA/BE specialist RSABE divergence · M13A vs FDA · which path for an HVD "...sponsor wants both jurisdictions in one submission. The reference scaling is incompatible because..." 1w ago embedded · ongoing in continuation · the response becomes the next thing read a thinking practice on record · almost a decade of public writing
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Where the thinking surfaces.

Channels · with cadence
/ LinkedIn · Sunita Nawale Live

Daily-cadence thinking.

Where Sunita has been writing in essay-form since 2021. Regulatory thinking, book reflections, leadership essays, and now the iFeed long-form practice. The primary distribution channel.

/ LinkedIn · iFeed Live

The company page.

iFeed's company page on LinkedIn. Where the practice surfaces under the iFeed brand specifically — manifesto pieces, methodology references, regulator-watch synthesis.

iFeed Follow the company page →
/ iFeed.com · Notes Live

Long-form weekly.

Long-form writing lives at iFeed.com/notes. Weekly cadence. Each piece anchors at iFeed and cross-posts to LinkedIn Articles. Read here, write back on LinkedIn.

/ YouTube · iFeed Planned

Talking-head explainers.

8–10 minute pieces on the immunity model, the methodology, regulator-watch commentary — planned. Format will auto-embed into the relevant iFeed.com articles when the channel opens. Activation is subject to interest and feasibility; we will not announce a launch date until the substrate is ready to defend it.

Cadence to be confirmed at launch Notify me at launch →
/ Podcast · iFeed Forthcoming

Practitioner conversations.

Interview-format conversations with practitioners working at the intersection of regulated life sciences and AI-native execution — in design. Guest pipeline being scoped; format and cadence will be confirmed at launch.

Format 30–45 min (planned) Notify me at launch →
/ iFeed Academy Pilot planned

Cohort learning.

Four cohort tracks under construction — EU AI Act readiness, validation of non-deterministic systems, GMP Annex 22, and ICH M10 bioanalytical method validation. Curriculum, faculty, and tuition posture are documented; pilot cohort activation is subject to interest and feasibility, and the open-intake cohort opens after the pilot closes successfully.

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The cadence.

What you can expect
/ Weekly

One long-form · three short-form.

Monday long-form lands at iFeed.com/notes and cross-posts to LinkedIn Articles. Three short-form thinking-out-loud posts during the week on Sunita's LinkedIn.

/ Monthly

Synthesis piece · regulator watch.

Cumulative reflection of the month's notes. Regulator watch synthesis (FDA · EMA · MHRA · HPRA · ICH · WHO PQ). Updated bibliography in the library.

/ Quarterly

Domain deep-dive.

One deep-dive per operational domain — bioanalytical, bioequivalence, clinical trials — rotating quarterly. Reading-list refresh in the library.

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What's worth writing back about.

Engagement framing
/ The conversations iFeed wants to be in

Write back if you are actually working on this.

  • You are classifying AI deployments against the EU AI Act high-risk taxonomy and the worked examples are missing
  • You are validating non-deterministic systems and the GAMP 5 framework needs reinterpretation
  • You are preparing for GMP Annex 22 finalisation in H2 2026 and need to know what the inspection-readiness gap looks like
  • You are running ICH M10 bioanalytical methods across multiple jurisdictions and need the convergence/divergence map
  • You are operating an AI/ML medical device with a PCCP question and need the FDA-cleared template
  • You are building an AI-native pharma startup and need quality systems architected from day one rather than retrofitted
  • You are an AI engineer moving into the regulated industries and need the substrate to be legible