// Services

Service Architecture

System Silos // Architecture Alignment

[ 01 ]

Pharma & Biotech

EU GMP Annex 11 FDA 21 CFR Part 11 FDA CSA GAMP 5 2Ed

Stop bleeding engineering hours on legacy validation debt.

CSV to CSA Migrations: We transition paper-heavy CSV protocols into modern, risk-based Computer Software Assurance (CSA) models to drastically reduce execution and documentation time, while maintaining compliance through critical thinking.
QMS & Manufacturing Automation: Validating complex software integrations for automated manufacturing lines, MES, and eQMS without triggering regulatory non-conformances or prolonged production downtime.
Paperless Traceability: Establishing agile, unscripted testing architectures that maintain full compliance while accelerating deployment.

[ 02 ]

EU MDR Article 117 ISO 13485 ISO 14971 IEC 62304 FDA PCCP

Navigate the transatlantic regulatory gap with auditor-ready documentation.

BSI / TÜV SÜD / Dekra Technical Files: We translate complex US software architectures and legacy product data into the exact, structured Technical Documentation formats European Notified Bodies demand.
Article 117 (Drug-Device) Bridging: Architecting the software compliance pathways for combination products, pre-filled syringes, and connected auto-injectors.
Agile Compliance Mapping: Integrating strict IEC 62304 software lifecycle requirements into modern Jira/Agile development workflows so your engineers can build without breaking compliance.
PCCP & Continuous Learning Compliance: Mapping FDA Predetermined Change Control Plans against EU AI Act Annex IV Section 2(f) requirements, establishing a compliant pathway for continuously-learning SaMD across both regulatory environments.

[ 03 ]

EU AI Act ISO/IEC 42001 FDA GMLP Guidance

Deploy autonomous agents and RAG applications in GxP environments without regulatory paralysis.

The "Friendly AI" Framework: Designing auditable guardrails for generative AI and LLMs operating within regulated quality systems.
EU AI Act Readiness: Classifying your AI-enabled tools against the latest European risk tiers and building the required transparency and human-in-the-loop documentation.
AI Agent Validation: Establishing continuous monitoring and validation protocols for autonomous data pipelines and AI-assisted compliance tools.

Submit your current regulatory constraints for a clinical diagnostic of your pipeline.