§ 02 / Services Bridging compliance and digital transformation.
Four practices that together cover the full regulatory and operational surface of a life-sciences organization — built for inspection-ready outcomes without slowing the work down.
§ 01 →
Quality Management
ISO-aligned quality management systems, audits, and design controls — built from gap analysis to ongoing internal review.
- Gap Analysis
- Quality Management Systems Build and Implementation
- Internal Audits / Supplier Audits / Mock Audits
§ 02 →
Regulatory Compliance
Submissions, remediation, and EU/US regulatory strategy — built around the realities of inspections and post-market obligations.
- Regulatory Submissions
- FDA QSub
- FDA 483 / Warning Letters Remediations
§ 03 →
cGxP
Validation, process optimization, and GLP testing across pre-clinical through early commercial — for peptides, biologics, devices, and combination products.
- Pre-Clinical / Clinical / Early Commercial
- Validation IQ / OQ / PQ
- Process Flow / Optimization
§ 04 →
Data & IT
Computer system validation, cloud-native cGxP architecture, and the data governance that makes modern compliance possible.
- Software Lifecycle Development and Validation
- Information Management Systems
- Data Readiness — Curation, Labeling and Governance
§ 02.1 Standards we work in
The frameworks behind every engagement.
ISO 13485 ISO 13485 International standard specifying Quality Management System (QMS) requirements for medical devices. ISO 9001 ISO 9001 The global standard for general quality management systems across all business sectors. ISO 14971 ISO 14971 The international standard for risk management application specifically for medical devices. IEC 62304 IEC 62304 The global standard defining software life cycle requirements for medical device software. 21 CFR 820 21 CFR 820 FDA Quality System Regulation (QSR) for medical device manufacturing, transitioning to QMSR. 21 CFR 210/211 21 CFR 210/211 FDA Current Good Manufacturing Practice (cGMP) regulations for manufacturing finished pharmaceuticals. EU MDR 2017/745 EU MDR 2017/745 Regulatory compliance framework and industry standard.