Core service lines offered as scoped project partnerships. Language below is engagement SOW framing — what gets delivered, under what controls, and how completion is evidenced.
01 · CMC / RA CMC & Regulatory Affairs
Sponsor need 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
02 · Quality Quality Systems — Design & Remediation
Sponsor need 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
03 · Audit Ready Inspection & Audit Readiness
Sponsor need 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
04 · AI + QMS AI Policy / Procedure + HITL in the QMS
Sponsor need Teams want AI leverage in quality workflows with controlled GxP risk and clear human accountability.
Policy and procedure rollout for human-in-the-loop AI in quality-system management: AI as decision support under qualified human oversight. Controls, roles, training linkage, and change control so AI use stays procedure-governed and audit-defensible.
- 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
05 · Training AI-Assisted Training System Deployment
Sponsor need Training needs to stay current with SOPs and change control as remediation and new procedures roll out.
Deploy AI-assisted, procedure-linked training under validation oversight and controlled procedures. Engagements cover training / compliance system design, rollout against SOP and change-control timelines, and LMS-adjacent process work so curricula stay current with the QMS — with human accountability retained.
- Training / compliance system design and rollout
- Procedure-linked, AI-assisted curriculum deployment
- LMS-adjacent process alignment under oversight
- Validation-aware controls and human sign-off paths
06 · CAPA AI-Assisted CAPA Project Management & Investigations
Sponsor need Sponsors need CAPA portfolios that close with strong root cause, clear ownership, and verified effectiveness evidence.
Structured CAPA investigation and program management with AI assist plus human-in-the-loop ownership of root cause, decisions, and closure. Designed for backlog reduction, stronger investigation quality, and milestone-visible CAPA portfolios with verified proof of outcomes.
- 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
07 · Coordination Cross-Firm / Program Coordination
Sponsor need 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
08 · GAME GAME as Engagement Operating System
Sponsor need Programs need clear priorities, visible dependencies, and milestones that close with proof of outcomes.
Run the engagement on GAME: 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