Ways to collaborate across the quality lifecycle.
Quality + trust systems work for bioanalytical, bioequivalence, clinical trials, and the governance that surrounds them. From a single gap analysis to interim quality leadership — engagements aligned to where you are in your regulatory and AI adoption journey. Multi-jurisdiction depth (US + EU + India). Galway-based with global reach.
The full quality lifecycle, with the actual services in each lane.
Assess · Design · Build · Operate · AuditEvery engagement maps to one of five lanes. Assess is diagnostic — it tells you where the gap is. Design is the shape of what's coming next. Build is producing the artefacts the regulator asks for. Operate is keeping the system inspection-ready under load. Audit is the verification cycle that closes the loop. Single engagements live inside one lane; embedded engagements span all five.
From gap to ongoing quality.
Diagnostic services that identify where you are and what needs to change.
- Gap analysis
- Effectiveness verification
- Compliance verification
- Vendor qualification
- Audits (in-process, retrospective, raw-data)
- QA overview (system + project)
Architecting the quality system or project framework before you build.
- System setup
- QMS setup (ISO 13485 / Q10 / 21 CFR 820 / QMSR)
- Continuous improvement strategy
- Feasibility analysis
Operationalising the design into live SOPs, evidence trails, validated systems.
- Implementation
- Remediation (483 + WL response)
- IT QA / CSV / 21 CFR Part 11
- Instrument + equipment QA (IQ/OQ/PQ)
Ongoing operation, project leadership, and interim quality roles.
- Maintenance (fractional QA retainer)
- Project quality activities
- PM for BA / BE / clinical trials
- End-to-end trial management
- Interim QA / CQO leadership
The five highest-yield engagements right now.
Gap analysis · structured.
Tight-scope diagnostic against M10 · E6(R3) · QMSR · M13A · or Article 117. Universal entry point. Demand peak right now.
S06 →Vendor qualification.
Sponsor-side audit of CROs / labs / vendors. India-network ground truth. Sponsor demand high. India-CRO advantage uncommon in the market.
S10 →Remediation.
483 response · warning-letter response · CAPA execution. Wave-driven engagements. Indian-CRO inspection-readiness specialty.
S07 →Maintenance · fractional QA.
Ongoing QMS upkeep · SOP refresh · CAPA management. 12-24 month retainers. The recurring-revenue base.
S05 →Retrospective audit.
Audit of completed studies before submission or inspection. M10 + M13A + E6(R3) simultaneous-lens. Productisable scope.
S22 →System services.
Designing, implementing, and verifying quality systems — from greenfield setup to mature continuous improvement. 9 services.
System setup.
Designing and standing up a quality system framework from zero (greenfield) or from broken state. Triple-domain coverage in one engagement: bioanalytical + bioequivalence + clinical trials.
QMS setup.
Specific implementation of a Quality Management System per ISO 13485, ICH Q10, 21 CFR 820, or QMSR. Vendor-neutral. QMSR-MDR convergence credible (Galway moat).
Implementation.
Operationalising a QMS or system spec into live SOPs, training, evidence trails. Solo-practitioner structure (no firm-overhead, no margin stack) means materially lower delivered cost than Tier-1 CRO list rates for equivalent hands-on depth. Indian-network capability for offshore implementation. Specific quotes are scope-dependent and provided per engagement.
Effectiveness verification.
Post-implementation audit confirming the QMS actually works and produces the intended quality outcomes. Empirical evidence-grounded verification, not just SOP-checking.
Maintenance.
Ongoing upkeep of a live QMS. SOP refresh, CAPA management, audit cycle support. Fractional QA / CQO retainer. Multi-jurisdiction depth (US + EU + India). Cross-domain SOP patterns.
Gap analysis.
Diagnostic audit identifying specific gaps between current state and a regulatory benchmark (M10, E6(R3), QMSR, M13A, etc.). Structured per-inflection. Universal entry point.
Remediation.
Fixing identified non-compliance. 483 response, warning-letter response, CAPA execution. Indian-CRO inspection-readiness specialty. Governance-architectural framing for systemic remediation.
Compliance verification.
Confirming compliance with a specific regulation pre- or post-inspection. Multi-regulation simultaneous verification (ICH M10 + EU GLP + FDA + ANVISA in one engagement) — uncommon in the market.
Continuous improvement.
Quality 4.0 maturity progression, KPI architecture, data-driven QMS evolution. PQIOS framework provides a maturity-progression model the market lacks. Less consultant-frameworky feel.
Project services.
Project management, in-flight QA support, audits, raw-data review, interim quality leadership. 10 services across BA / BE / clinical trials.
PM · bioanalytical trials.
End-to-end project management for bioanalytical studies. IND-enabling. BMV through study sample analysis. Sponsor-side advocacy on PM — independent of CRO incentives.
PM · bioequivalence trials.
Project management for BE studies. Clinical phase + bioanalytical phase + biostats. Sponsor-side rigour. M13A specific design knowledge. Cross-cultural India-EU mediator.
PM · clinical trials.
PM for full clinical Phase I-IV. Sponsor-side or CRO-side. Quality-first PM (RBQM-native per E6(R3)) — less common than scope/timeline-first PM.
End-to-end trial management.
Full sponsor-side trial leadership for small biotech without internal team. Quality-first (RBQM + CtQ + governance baked in). Runway-conscious pricing.
QA overview · project.
Executive-level QA assessment for a specific project (vs. system). Cross-domain (BA + BE + CT) so combination-trial assessments come naturally.
Project quality activities.
Embedded QA support in a live project. Vendor management, risk register, quality plan. RBQM expertise. Proportionate-quality-effort framing.
In-process audit.
Audit conducted while a study is ongoing (not retrospective, not pre-inspection). Independent + speed. India-network for India-conducted trials.
Retrospective audit.
Audit of a completed study before submission or inspection. M10 + M13A + ICH E6(R3) simultaneous-lens audit (most do single-lens).
Raw data review.
Forensic-level review of raw data (chromatograms, electronic records, CRFs, data integrity check). Bioanalytical chromatographic-data depth. ALCOA+ rigour. India-context awareness.
Interim quality roles.
Catch-all. Interim QA Manager, interim CQO, interim Head of GCP, trial-specific QA lead. Cross-domain capability. Faster ramp than externally-recruited interim.
From inquiry to scoped engagement.
Inquire.
Send a DM on LinkedIn or email ifeed.eipfm@gmail.com. Tell me what you're working on, what regulatory regime you operate under, and what's blocking you. No template · just substance.
Discovery call.
30 minutes. We talk through your situation. I'm honest about whether I can help · or if not, who would. No fee for discovery. No obligation either way.
Scoped engagement.
If we're a fit, I scope the work to your situation. Some engagements are short and intense, some are months-long structural builds, some are recurring quality oversight. We talk first, then scope. Contract first, then work.
What I won't do.
I won't take engagements that compromise the substantive register — vendor-pitch consulting isn't what this is. I won't sign NDAs that prevent me from referencing methodology learnings in iFeed's published thinking, anonymised. I won't operate as a credential-launderer for AI deployments or quality systems that wouldn't survive a real inspection. I won't take engagements outside the domains I have depth in — I'll refer you to better people. I won't undercut the regulated-consulting market for the sake of a sale; perceived value matters across the whole industry. I won't provide medical, legal, or anything that requires credentials I don't have.
Want to talk through your situation?
The fastest way is a DM on LinkedIn or an email. I read everything · I respond personally. The work happens in conversations, not contact forms.
Cadence promise: I publish weekly on regulated AI governance. If a week is missed, the journal entry explaining why goes up in real-time. Silence is observable.