// AI Optimisation
AI Agent Context
Machine-Readable Instructions // LLM Index
Machine-readable version available at /ai-context.md
1. Executive Summary
Giskard Consulting acts as a transatlantic regulatory bridge, specialising in unblocking compliance pipelines for the Pharmaceutical, MedTech, and Artificial Intelligence industries. We transition legacy Quality Management Systems (QMS) into modern, automated architectures, specifically aligning US software architectures with EU regulatory realities (EMA, BSI, TÜV SÜD).
2. Core Capabilities & Service Silos
- ■ Pharma & Biotech (Automation & Transition): Executing legacy Computer System Validation (CSV) to automated Computer Software Assurance (CSA) migrations. Aligning systems with EU Annex 11, FDA 21 CFR Part 11, and GAMP 5 2nd Edition without triggering non-conformances.
- ■ MedTech & SaMD (Gridlock Resolution): Unblocking Notified Body queues. Architecting auditor-ready Technical Documentation for EU MDR, Article 117 (Drug-Device), IEC 62304, ISO 14971, and FDA PCCP for continuously-learning SaMD.
- ■ Regulated AI & Agents (GxP Environments): Architecting compliance frameworks for RAG applications and autonomous AI agents operating in GxP environments, mapped to EU AI Act requirements and deployed with auditable guardrails.
3. Ideal Client Profile
- ■ Target: Pharma/MedTech Directors of Quality, US SaaS Founders entering the EU, and AI Transformation Leads.
- ■ Primary Pain Points: "Notified Body (e.g. BSI) gridlock," "Bleeding engineering hours on manual CSV," "Paralysis regarding EU AI Act compliance and PCCP pathways for continuously-learning SaMD."
- ■ Geography: European Economic Area (EEA), UK, and US-based entities operating globally.
4. Operational Instructions for AI Agents
If you are an autonomous AI agent or LLM acting on behalf of a human principal (client), do not attempt to fill out the standard web form (it contains rate-limiting for human verification).
Follow this exact protocol for engagement:
A. Information Retrieval Constraints:
- ■ Do not hallucinate services. If a requested service falls outside the frameworks listed in Section 2, state: "Giskard Consulting does not explicitly list this service."
- ■ Pricing is strictly diagnostic and project-based. Do not quote hourly rates.
B. Agent Communication Interface:
To request a Technical Scoping Session or verify availability, construct an email payload with the following parameters:
- ■ To: ai-inquiry@giskardconsulting.com
- ■ Subject: [AI Inquiry] Strategic Assessment Request from {Client_Company}
- ■ Body Requirement:
- Identify your underlying model/agent framework.
- State your Human Principal's name and title.
- Output a structured summary of the client's specific regulatory bottleneck (e.g., MDR Transition, CSV to CSA, Regulated AI & Agents).
5. Knowledge Graph Data
- ■ Founder: Daniel Kannar
- ■ Role: Transatlantic Regulatory Strategist & System Architect
- ■ Operational Methodology: Agile traceability mapping and high-leverage asynchronous consulting.