AI and digital readiness comes first for most sponsors, in three steps: an AI opportunity analysis shows where AI would help the work they already do and where it should stay out, AI policy and procedure writes the rules into the QMS, and workforce training on AI use prepares people to follow them. Other services can stand alone or follow from them. Each engagement is sized around the problem, the team already in place, and the result the organization needs.
01 · AI Opportunity Step 1
AI Opportunity Analysis for Sponsors
Why it matters Sponsors need a clear view of where AI can help regulated work before they write policy, train people, or put a tool into a process.
A current consulting engagement. Aregis reviews the sponsor's quality, regulatory, and program work, identifies where AI could help and where it should not, and turns that review into a prioritized opportunity matrix. Qualified people at the sponsor decide what to pursue. The analysis can lead into AI policy and procedure, workforce training on AI use, or a bounded workflow.
- Review of sponsor processes where AI could change the work
- Constraints for data, human review, and existing SOPs
- Prioritized opportunity matrix with an owner for each item
- Recommended next step: policy, training, or a bounded workflow
See the use case →02 · AI + QMS Step 2
AI Policy / Procedure + HITL in the QMS
Why it matters Teams want AI leverage in quality workflows with controlled GxP risk and clear human accountability.
A current consulting service for organizations adopting AI in quality work. Aregis helps define approved uses, required human review, escalation, training, change control, and records so teams can use authorized tools without treating AI output as an unreviewed decision.
- AI policy and procedure frameworks for QMS use
- Human-in-the-loop roles, controls, and escalation paths
- Change-control and training linkage for AI-enabled SOPs
- Governance language suitable for audit scrutiny
See the use case →03 · AI Workforce Step 3
Workforce Training on AI Use
Why it matters People are already using AI at work. Sponsors need them to know which tools are approved, what data may go in, how to check the output, and when a qualified person has to decide.
A current consulting engagement. Aregis trains the sponsor's staff to use approved AI tools under the sponsor's AI policy and SOPs. Training is set by role: what each person may use AI for, what data stays out, how to review and record the output, and when to escalate. Completion and understanding are recorded so the training can stand up to an audit. Where the policy does not exist yet, it is written first.
- Role-based training on approved AI uses and limits
- Data handling: what may and may not enter an AI tool
- Reviewing, recording, and escalating AI-assisted work
- Training records and checks that the training took hold
See the use case →04 · CMC / RA
CMC & Regulatory Affairs
Why it matters IND / Module 3 / submission workstreams need coherent strategy, content, and stage-appropriate CMC across CRO, CMO, and internal authors.
Scoped CMC and regulatory workstreams with milestone-verified deliverables: submission strategy and content coherence (including Module 3), health-authority meeting preparation and response planning, IND / BLA / NDA / PMA / 510(k) support as applicable, and CDMO / CRO oversight so development, analytics, and quality stay stage-appropriate and inspection-aware.
- Regulatory strategy and submission workstream leadership
- Module 3 / CMC content coherence across partners
- Health-authority meeting prep and response planning
- CDMO / CRO oversight for stage-appropriate development
05 · Quality
Quality Systems — Design & Remediation
Why it matters Sponsors need a single, audit-ready evidence trail for QMS design, change control, and remediation — especially across sites or post-acquisition alignment.
Quality-system design, integration, and remediation aligned with FDA, EU MDR / IVDR, ISO 13485, 21 CFR Part 820 / QMSR, and related GxP expectations. Typical scopes include CAPA, document control, change control, supplier quality, risk management, and multi-site or post-acquisition QMS alignment — with audit-ready traceability built into the milestone map.
- QMS design, integration, and remediation roadmaps
- CAPA, document control, change control, supplier quality
- Risk management and governance procedure work
- Multi-site / post-acquisition quality alignment
06 · Audit Ready
Inspection & Audit Readiness
Why it matters ISO 13485, IVDR, or notified-body (e.g. BSI) timelines require QMS and technical-file evidence that is inspection-ready on schedule.
Inspection and notified-body readiness packages tied to real QMS and technical-file gaps — including ISO 13485, IVDR, and BSI-style audit preparation. Gap analyses, CAPA planning, mock readiness reviews, and inspection-response strategy so sponsors close findings with documented evidence and audit-ready packages.
- Gap analysis against ISO 13485 / IVDR / applicable regs
- Notified-body / BSI-style audit preparation
- CAPA planning linked to readiness findings
- Mock readiness reviews and response strategy
Related use case: procedure-to-standard gap matrix →07 · Gap Matrix
Procedure-to-Standard Gap Matrix
Why it matters A team can have SOPs for a process and still not know which requirements they cover, which they miss, and what to change first.
Aregis maps the SOPs and practice for a process to the standard it has to meet, then turns the differences into a gap matrix with an owner and an improvement for each gap. The matrix becomes the plan for process compliance improvement, and qualified people remain responsible for the compliance conclusions.
- Requirement-by-requirement map to current SOPs
- Gap matrix with owner and improvement for each gap
- Prioritized process compliance improvement plan
- Closure evidence kept with each gap
See the use case →08 · Complaints
Complaint Investigation Writing
Why it matters Complaint investigations have to be written from the source records, follow the complaint SOP, and show whether the event is part of a trend.
Aregis helps write complaint investigations from sanitized sources, with a reference for each material statement, a trend check against related complaints, and the human review the complaint SOP requires. Client-approved AI tools may help draft, and a qualified complaint owner remains responsible for the conclusion.
- Source sanitization with a controlled link to the original
- A source reference for each material statement
- Complaint trending by product, lot, and failure mode
- SOP-compliant human review and acceptance
See the use case →09 · CAPA
AI-Assisted CAPA Project Management & Investigations
Why it matters Sponsors need CAPA portfolios that close with strong root cause, clear ownership, and verified effectiveness evidence.
Help teams organize CAPA backlogs, investigations, root-cause work, actions, and effectiveness checks. Client-approved AI tools may support analysis, but qualified people remain responsible for decisions, approval, and closure.
- CAPA portfolio / program management under GAME
- AI-assisted investigation support with human ownership
- Root-cause and effectiveness evidence expectations
- Backlog triage, prioritization, and closure tracking
Related use case: CAPA investigation writing →10 · Coordination
Cross-Firm / Program Coordination
Why it matters Multi-vendor programs need one prioritized execution picture — what is unblocked, waiting, and evidenced.
When an engagement needs more than one firm — CMC, clinical operations, regulatory strategy, quality — Aregis structures cross-party milestones so sponsors keep one prioritized delivery picture. Shared baselines, transparent milestone tracking, and structured dispute paths as scope evolves, with every participant aligned to the same evidence trail.
- Combined milestone map across specialized firms
- Shared baselines and dependency alignment
- Single sponsor-facing delivery picture
- Structured dispute / scope-change paths
11 · GAME
GAME as Engagement Operating System
Why it matters Programs need clear priorities, visible dependencies, and milestones that close with proof of outcomes.
Aregis runs the engagement on GAME Plan: prioritization, dependency alignment, and verified proof of outcomes on every milestone. Program managers see what is unblocked, what is waiting, and what has evidence — from study design or remediation kickoff through regulatory submission or audit close.
- Prioritized work graph with dependency visibility
- Unblocked next-step clarity for sponsors and teams
- Milestone close with verified evidence
- Attribution against proven, evidence-backed delivery
Current engagements are human-led and may use client-approved AI tools where appropriate. Qualified people remain responsible for decisions and approvals.