In choosing PharmaX GxP Compliance and Strategic consulting solution, clients trust in our unwavering commitment to excellence, regulatory expertise, and a collaborative approach that empowers them to achieve and maintain the highest standards of quality and compliance in the pharmaceutical industry. We are committed to partnering with our clients to streamline processes, enhance product quality, and ultimately contribute to the delivery of safe and effective medicines to patients worldwide.
GxP Compliance & Strategic Consulting
Regulatory Compliance
We provide expert guidance to ensure compliance with global regulatory requirements, including Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).Quality Management Systems
Our services include the development and implementation of robust Quality Management Systems (QMS) to enhance product quality, ensure regulatory compliance, and drive continuous improvement.Audits and Inspections
PharmaX conducts comprehensive audits and inspections to identify areas of improvement, assess compliance levels, and provide strategic recommendations to strengthen quality systems.Training Programs and Documentation Support
We offer customized training programs designed to equip pharmaceutical professionals with the knowledge and skills needed to navigate regulatory complexities and ensure a culture of compliance within organizations. Our team assists in the creation, review, and management of essential documentation, including Standard Operating Procedures (SOPs), validation protocols, and regulatory submissions.Risk Management
PharmaX provides tailored risk management solutions to identify, assess, and mitigate risks across the pharmaceutical product lifecycle, ensuring a proactive approach to quality and compliance.Success
stories
Validation Consulting for a Greenfield SAP S/4HANA Implementation at a Medical Device Manufacturer
Project Details
- Industry: Life Sciences
- Sector: Medical Device Manufacturing
- Location: Germany
- Challenge: Needed validation for MES PAS-X upgrade and SAP S/4HANA rollouts with GxP compliance
Our Solutions
- Developed hybrid-agile validation framework aligned with agile implementation
- Performed FRA at product backlog level
- Conducted GxP assessments at transactional level
- Proposed reusable Fiori App validation methodology
- Suggested a master template-based rollout approach for multiple sites
Value Added
- Ensured GxP-compliant SAP and MES validation
- Enabled scalable validation across global sites
- Improved efficiency and clarity in validation of Fiori apps
Auditing & Remediation: Pharma Manufacturing Company’s CMO Audit Partner With PharmaX Solutions
Project Details
- Industry: Life Sciences
- Sector: Pharmaceuticals
- Location: Pan Europe
- Challenge: Difficulty in auditing multiple CMOs across Europe consistently and effectively
Our Services
- Deployed PharmaX Auditing and Remediation Toolkit
- Aligned auditing model to customer requirements
- Deployed dedicated auditing teams to various CMOs
- Provided ongoing audit and remediation support through tailored models
Value Added
- Streamlined CMO auditing process
- Ensured consistent compliance across vendors
- Reduced internal audit burden for the customer
Computerised System Validation: MES Validation for Pharma Manufacturing Company
Project Details
- Industry: Life Sciences
- Sector: Pharmaceuticals
- Location: Denmark, Spain
- Challenge: Validation of MES system for both site and global rollouts
Our Services
- Used PharmaX MES Validation Toolkit
- Provided on-site validation experts
- Developed optimized validation processes
- Maintained system in a validated state through structured support
Value Added
- Ensured timely validation of MES system
- Minimized compliance risks during rollouts
- Created a sustainable validated environment