Sparsh Strategic Consulting | GxP QA | Healthcare
Touching Human Lives Through Quality and Innovation
Our Services
Global GxP Audits and Compliance
Our comprehensive GxP QA audit services identify compliance risks, assess quality processes, and ensure your organization is prepared for any regulatory inspection.
Types of Audits:
• Investigator site audits
• Clinical data management audits
• Biostatistics and statistical programming audits
• Pharmacovigilance audits (clinical and marketed products)
• Vendor and subcontractor audits
• Computer System Validation (CSV) audits
• Good Distribution Practices (GDP) audits
• For-cause audits
Deliverables:
• Detailed audit reports with actionable recommendations
• Root cause analysis and CAPA management
Regulatory Inspections
Prepare for regulatory inspections and manage post-inspection activities with expert guidance.
Key Services:
• Mock inspections and readiness assessments
• Inspection-day support
• Regulatory response preparation (FDA, EMA, MHRA, PMDA, DCGI, NMPA, Taiwan FDA, MFDS, and other health authorities)
GxP Consultancy Services
We provide end-to-end support to help life sciences companies maintain GxP QA compliance across clinical development, manufacturing, and laboratory processes.
Our GxP Areas:
• GCP, GVP, GCLP, GLP, GMP, CSV (Computer Systems Validation), and GDP (Good Distribution Practices)
• Quality Management System (QMS) development and optimization
• Vendor qualification and supplier oversight
Strategic Consulting in Quality and Risk Management
Our strategic advisory services are designed to enhance quality systems, mitigate risks, and ensure robust clinical development processes.
Consulting Services:
• Risk management across the clinical development cycle
• GxP QA and QMS system optimization
• Strategic quality improvement initiatives
• Bespoke consultations on serious GxP non-compliance cases
Training and Education
Customized training programs to equip your teams with the knowledge and skills to maintain compliance and manage audits effectively.
Training Programs:
• Impactful GCP training for site teams, sponsors, and CROs
• Inspection readiness and audit handling
• Data integrity and GxP risk management
• CAPA implementation workshops
New Tech and Innovation Consulting
We help companies developing medtech, wearables, and innovative healthcare solutions integrate quality and regulatory considerations (GxP QA, QM and RM) from the start.
Our Focus Areas:
• Digital health technology and software as a medical device (SaMD)
• Quality and compliance for wearables and connected devices
• Data privacy, security, and integrity
Strategic Consulting for Clinical Development of Medicines
We provide end-to-end strategic consulting to guide life sciences companies through the complex clinical development landscape while ensuring a holistic approach to patient care and healthcare outcomes.
Key Services:
• Clinical development strategy design
• Integrated approach to drug development
• Cross-functional team collaboration
• Holistic healthcare perspective
• Regulatory and clinical development roadmap (GxP)
• Post-approval safety and monitoring support
Industries we serve
We work with a diverse range of organizations, ensuring that each client’s unique needs are met with tailored solutions.
Our Key Sectors:
• Pharmaceuticals
• Biotechnology
• Medtech and Wearables
• Contract Research Organizations (CROs)
• Site Management Organizations (SMOs)
• Academic Research Institutions