Regulatory Compliance & Data Protection
Our services and technology platform are built from the ground up to meet the most stringent regulatory requirements, including 21 CFR Part 11, GDPR, HIPAA, GxP, ICH-GCP, MedDRA, FDA, CDISC, and GAMP 5. Compliance is not an afterthought -- it is embedded in everything we do.
Compliance at the Core of Everything We Do
At MTK Pharma Services, regulatory compliance is not a checkbox exercise — it is a foundational principle embedded into our organisational culture, technology architecture, and service delivery processes. With decades of combined experience in pharmaceutical regulations, our team ensures that every clinical trial we support meets or exceeds regulatory expectations.
From pre-study planning through to regulatory submission, our dedicated compliance team works alongside project teams to implement and monitor adherence to all applicable regulations. We maintain an active regulatory intelligence programme to stay ahead of evolving requirements across global markets.
Global Coverage
FDA, EMA, MHRA, PMDA, TGA & moreDedicated Team
Compliance officers & QA specialistsAudit Ready
Always inspection-ready systemsContinuous Updates
Real-time regulatory intelligence
Comprehensive Compliance Framework
We maintain a rigorous compliance programme that encompasses regulatory standards, data protection regulations, and industry best practices across all our services and technology platforms.
21 CFR Part 11
GDPR
GxP
HIPAA
ICH-GCP
MedDRA
FDA
CDISC
GAMP 5
21 CFR Part 11
FDA's regulation governing electronic records and electronic signatures in the pharmaceutical and life sciences industry.
21 CFR Part 11 Compliance
Our entire technology platform is designed, developed, and validated in compliance with 21 CFR Part 11, the FDA regulation that establishes criteria for the acceptance of electronic records and electronic signatures. Every system within our platform incorporates the required technical and procedural controls.
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Comprehensive Audit Trail
Computer-generated, timestamped audit trails recording the date, time, operator identity, and nature of all record changes, additions, and deletions.
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Electronic Signatures
Legally binding electronic signatures with unique user identification, authentication requirements, and signature manifestations linking to signed records.
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Access Controls
Role-based access control, unique user credentials, password policies, automatic logoff, and system access restrictions to authorised personnel only.
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System Validation
GAMP 5 risk-based validation approach with IQ/OQ/PQ protocols, traceability matrices, and ongoing periodic review to ensure continued validated state.
GDPR
The EU General Data Protection Regulation governing the processing of personal data of individuals within the European Union and European Economic Area.
GDPR Compliance
As a UK-based organisation supporting clinical trials across Europe and globally, we maintain full compliance with the General Data Protection Regulation (GDPR) and the UK Data Protection Act 2018. Our data protection framework ensures that all personal data, including sensitive clinical trial participant data, is processed lawfully, transparently, and securely.
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Privacy by Design
Data protection principles are integrated into the design of all systems and processes from the outset, including data minimisation and pseudonymisation.
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Data Processing Agreements
Comprehensive DPAs with all sponsors and sub-processors, clearly defining roles, responsibilities, and data processing terms per GDPR Article 28.
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Cross-Border Data Transfers
Appropriate safeguards for international data transfers including Standard Contractual Clauses (SCCs) and Transfer Impact Assessments.
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Data Subject Rights
Established processes for handling data subject access requests, right to erasure, data portability, and other GDPR data subject rights.
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Breach Notification
Documented breach detection, assessment, and notification procedures compliant with the 72-hour GDPR notification requirement.
Additional Compliance Standards
ICH-GCP (E6 R2)
All clinical services are delivered in full compliance with the International Council for Harmonisation Good Clinical Practice guidelines, ensuring the safety and rights of trial participants are protected and data integrity is maintained.
- IRB/EC compliance oversight
- Protocol adherence monitoring
- Informed consent processes
- Source data verification
GAMP 5 Validation
Our technology platform follows the ISPE GAMP 5 risk-based approach to computerised system validation, ensuring that all electronic systems used in regulated environments are fit for their intended purpose.
- Risk-based validation approach
- IQ/OQ/PQ documentation
- Requirements traceability
- Periodic review programme
CDISC Standards
Full implementation of CDISC data standards across our services and technology platform, ensuring regulatory-compliant data formats for FDA, EMA, and PMDA submissions worldwide.
- CDASH-compliant CRF design
- SDTM dataset standards
- ADaM analysis datasets
- Define.xml and controlled terminology
HIPAA Compliance
Our platform and services comply with the Health Insurance Portability and Accountability Act, ensuring the protection of individually identifiable health information in clinical research settings.
- Protected Health Information (PHI) safeguards
- Administrative, physical & technical controls
- Business Associate Agreements
- Breach notification procedures
GxP Compliance
Comprehensive Good Practice (GxP) compliance spanning GCP, GLP, GMP, and GDP requirements, ensuring all activities meet the quality standards mandated by regulatory agencies worldwide.
- Good Clinical Practice (GCP)
- Good Laboratory Practice (GLP)
- Good Manufacturing Practice (GMP)
- Good Documentation Practice (GDP)
MedDRA Coding
Full implementation of the Medical Dictionary for Regulatory Activities (MedDRA) for standardised medical terminology coding across all clinical data management and safety reporting activities.
- MedDRA-compliant adverse event coding
- Medical history standardisation
- Version management & migration
- WHODrug integration for concomitant medications
FDA Regulatory
Deep expertise in FDA regulatory requirements spanning IND, NDA, BLA, and 510(k) submissions, ensuring all clinical data, systems, and processes meet FDA expectations for approval.
- eCTD submission format compliance
- FDA inspection readiness
- Pre-submission meeting support
- Post-market surveillance requirements
Enterprise-Grade Security
Protecting clinical trial data is paramount. Our multi-layered security architecture encompasses physical, network, application, and data-level controls to safeguard sensitive clinical information throughout its lifecycle.
Encryption
AES-256 encryption at rest and TLS 1.3 in transit for all clinical data across every platform module.
Access Control
Role-based access with multi-factor authentication, session management, and IP whitelisting capabilities.
Infrastructure
SOC 2 Type II audited data centres with redundant architecture, automated failover, and 99.9% uptime SLA.
Business Continuity
Comprehensive disaster recovery with RPO < 1 hour, automated backups, and annual DR testing with documented results.
Our Compliance Process
A systematic, risk-based approach to compliance that ensures regulatory adherence at every stage of the clinical trial lifecycle.
Assessment & Planning
Comprehensive regulatory assessment to identify all applicable requirements based on study design, therapeutic area, geography, and data types. Development of a tailored compliance plan.
Implementation & Validation
System configuration, GAMP 5 validation, SOP development, and team training. All systems are validated before go-live with complete IQ/OQ/PQ documentation and traceability.
Monitoring & Audit
Continuous compliance monitoring through automated checks, periodic internal audits, CAPA management, and real-time dashboards. Proactive identification of compliance gaps.
Review & Improvement
Regular management reviews, lessons learned integration, regulatory intelligence updates, and continuous improvement initiatives to strengthen the compliance framework.
Quality Assurance & SOPs
Our robust Quality Management System (QMS) underpins all compliance activities, ensuring that every process is documented, controlled, and continuously improved. Our SOP library covers all aspects of clinical data management and technology operations.
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Comprehensive SOP Library
Over 100 SOPs covering data management, programming, biostatistics, technology operations, and quality assurance processes, all version-controlled and regularly reviewed.
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CAPA Management
Structured Corrective and Preventive Action (CAPA) system for tracking, investigating, and resolving quality issues with root cause analysis and effectiveness verification.
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Training & Competency
Mandatory compliance training programme for all staff with role-specific curricula, regular refresher courses, and competency assessments tracked in our LMS.
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Internal Audit Programme
Scheduled and risk-based internal audits across all departments and systems, with findings tracked to closure and trends analysed for systemic improvements.
Regulatory Authority Alignment
Our platform and services are designed to meet the requirements of major regulatory authorities worldwide, supporting global clinical trial programmes.
FDA (United States)
IND/NDA/BLA submissions, 21 CFR Part 11, eCTD format, FDA inspection readiness, pre-submission meetings
EMA (European Union)
CTA submissions, EudraVigilance, GDPR alignment, Annex 11 compliance, EU CTR readiness
MHRA (United Kingdom)
UK clinical trial applications, MHRA inspection support, UK GDPR, post-Brexit regulatory alignment
PMDA & Other Agencies
Japan PMDA submissions, TGA (Australia), Health Canada, ANVISA (Brazil), and other global regulatory bodies
Questions About Our Compliance Standards?
Our compliance team is available to discuss our regulatory framework, security measures, and validation documentation. Contact us for a detailed compliance overview.