Empower Your Product Journey with X Pharma Plus Compliance, Audit, and Validation Services
Ensuring regulatory compliance in pharmaceuticals, biotechnology, medical devices, and healthcare is critical. X Pharma Plus offers comprehensive Compliance, Audit, and Validation services to help organizations meet GxP, ISO, and FDA standards while streamlining processes for global quality assurance. Our services focus on effective compliance management, pharmaceutical compliance consulting, and risk-based assessment to drive operational excellence.
Compliance, Audit, and Validation Services – Overview
For organizations in pharmaceuticals, biotech, genomics, chemicals, medical devices, and supply chain management, this question is complex. Companies must navigate stringent quality, safety, and compliance requirements across multiple geographies.
Regulatory trends are increasingly moving toward global harmonization, emphasizing robust and sustainable quality practices. Whether you are a manufacturer, supplier, or service provider, your market expansion, continual improvement, and customer satisfaction depend on maintaining high-quality standards.
X Pharma Plus Regulatory Compliance, Audit, and Validation Center of Excellence (CoE) helps organizations achieve compliance with:
- cGMP (Current Good Manufacturing Practices)
- GCP (Good Clinical Practice)
- GDP (Good Distribution Practice)
- GLP (Good Laboratory Practice)
- GPvP (Good Pharmacovigilance Practice)
- GxP Computer System Validation (CSV)
Our team provides tailored solutions addressing your unique compliance challenges, supporting both manual and automated processes to meet evolving regulatory expectations.
Pharma Quality and Compliance Services
Ensuring adherence to global regulatory standards through robust quality and compliance frameworks.
Documentation, SOP Writing and Review Services
Developing clear, compliant, and audit-ready SOPs and documentation to support operations.
Pharma GxP Audit Services
Comprehensive audits and mock inspections to assess, strengthen, and maintain GxP compliance.
Pharma Computer System Validation (CSV) and
Computer Software Assurance (CSA) Services
Validating and assuring computerized systems for accuracy, reliability, and regulatory compliance.
Quality Management System (QMS) Remediation and Establishment Services
Designing, implementing, and remediating QMS frameworks to meet evolving industry and regulatory requirements.
End-to-End Regulatory Compliance Services
Delivering complete compliance solutions across the product lifecycle for seamless market readiness.
Compliance, Audit, and Validation Services
Quality and Regulatory Compliance ensures that pharmaceutical products and processes consistently meet global standards, safeguarding patient safety and maintaining regulatory approval.
- cGMP, ISO/IEC 17025:2017
- OECD GLP Guidelines
- EURACHEM/CITAC Analytical Quality Guides
- 21 CFR Part 58
- WHO, UK, and Health Canada GLP Guidelines
- OSHA Standards
- Applicable ICH Guidelines
Good Laboratory Practice (GLP) ensures the reliability, integrity, and reproducibility of non-clinical laboratory studies by establishing standardized procedures, documentation, and quality controls.
- Laboratory accreditation support
- Analytical procedure compliance
- Non-clinical study adherence and reporting
Good Clinical Practice (GCP) & Good Pharmacovigilance Practice (GVP) ensure the ethical conduct, safety, and data integrity of clinical trials while monitoring, assessing, and managing the safety of medicinal products throughout their lifecycle.
- ICH E6, E2B(R3), E2C(R2) guidelines
- Safety reporting for INDs, BA/BE studies, and post-marketing products
- Electronic submission standards for ICSRs
- Pharmacovigilance planning and risk evaluation
Information Security & Computer System Validation (CSV) ensures that pharmaceutical IT systems are secure, reliable, and compliant with regulatory standards, protecting data integrity, confidentiality, and system functionality.
- ISO 27001/27002 Information Security Standards
- US FDA 21 CFR Part 11 compliance
- EU GMP Annex 11 & Japanese ERES Guidelines
- GAMP 5 risk-based approaches for GxP computerized systems
- Software validation aligned with FDA and ICH QSEM standards
X Pharma Plus delivers actionable insights, sustainable improvements, and measurable compliance outcomes, empowering your organization to confidently navigate global regulatory landscapes.