Our integrated Quality Management System is purpose-built for contract research and development manufacturing. Every process, protocol, and personnel interaction is governed by a framework that ensures client projects meet the highest standards of scientific rigor, regulatory compliance, and data integrity — from early-stage development through commercial supply.
ISO Certification & Standards Framework
Madin Life Sciences holds ISO 9001:2015 certification with ongoing alignment. Our QMS also integrates the requirements of ICH Q10, providing a pharmaceutical quality system model that underpins every CRO and CDMO engagement we undertake.
ISO 9001:2015
Certified quality management for all R&D and manufacturing services with annual surveillance audits.
ICH Q10 alignment
Pharmaceutical quality system model applied across development, scale-up, and commercial phases.
ICH Q7 / Q8 / Q9
Active pharmaceutical ingredient GMP, quality by design, and risk management principles embedded in project workflows.
GMP & GLP Compliance
Good Manufacturing Practice (GMP)
EU GMP Annex 1, 11, and 13 adherences
21 CFR Parts 210 & 211 compliance
Cleanroom qualification and environmental monitoring
Equipment qualification (IQ/OQ/PQ) and calibration
Batch record review and release procedures
Out-of-specification (OOS) and deviation management
Annual product review (APR) and CAPA programs
Good Laboratory Practice (GLP)
OECD GLP principles for non-clinical studies
Study director and quality assurance unit framework
Raw data documentation and retention protocols
Instrument validation and reference standard management
Method transfer and cross-validation support
Laboratory notebook standards and audit trails
Stability study design and ICH-compliant reporting
QA & QC Framework
Document Management
Electronic Document Management System (eDMS)
Electronic Document Management System (eDMS)
Electronic signatures (21 CFR Part 11)
Master documents register and distribution control
Testing Protocols
Validated analytical methods per USP/ Ph. Eur. /ICH
In-process and release testing schedules
Reference standard qualification
Specification management and change control
Internal Audits
Risk-based annual audit calendar
Trained internal auditor program
Audit findings tracking in CAPA system
Client-facing audit facilitation and hosting
Change Control & Risk
Formal change control board (CCB) process
ICH Q9 risk assessment (FMEA / HACCP)
Impact assessments for regulatory submissions
Change notification to clients and authorities
Quality Policy — Five Core Principles
01. Compliance
Unwavering adherence to global GLP, GMP regulations and client contractual quality requirements at every stage.
02. Innovation
Continuous adoption of advanced technologies and methodologies to strengthen service quality and delivery timelines.
03. Excellence
Right-first-time delivery of high-quality data, documentation, and product — every project, every batch.
04. Integrity
Transparent, data-driven decision making with full traceability and accountability throughout all services.
05. Improvement
A systematic culture of continuous improvement driven by metrics, client feedback, and regulatory evolution.
Quality Policy — Five Core Principles
Quality Assurance
System ownership, GMP compliance oversight, CAPA management, client audit coordination, and regulatory submissions support.
Quality Control
Analytical testing, environmental monitoring, stability programs, method validation, and release testing across all product types.
Regulatory Affairs
Submission preparation, regulatory intelligence, dossier management, and agency liaison services for client projects.
Document Control
eDMS administration, SOP lifecycle, training records management, and controlled distribution of quality documents.
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Built on Expertise. Driven by Responsibility. Focused on Results.
Our strength lies in the people, processes, and values that shape our scientific culture.
