SLA QA/QC and CAPA oversight India
SLA QA/QC and CAPA oversight India SLA QA/QC and CAPA oversight India Clintask offers SLA QA and QC programs to ensure that outsourced and managed service partners meet contractual and regulatory quality expectations. Our CAPA and deviation tracking frameworks provide unbiased visibility and enable sponsors to achieve consistent compliance outcomes across Indian operations.
GxP and QMS setup for eClinical companies
GxP and QMS setup for eClinical companies GxP and QMS setup for eClinical companies- (India) Clintask provides full QMS setup and operationalization support for Indian pharma, biotech, and technology-enabled service providers. Our frameworks comply with GxP, ISO, and regulatory standards, ensuring inspection readiness for global clients. We also provide shared QA roles, QaaS, and Validation […]
DPDP Act and GDPR compliance consulting
DPDP Act and GDPR compliance consulting DPDP Act and GDPR compliance consulting- (India) Clintask supports organizations in aligning their data management practices with India’s Digital Personal Data Protection (DPDP) Act 2023, ensuring lawful processing, consent, cross-border transfer management, and privacy-by-design implementation. Our services integrate data protection impact assessments (DPIA), privacy risk mapping, and IT-GxP validation […]
Data privacy compliance under APPI and GDPR
Data privacy compliance under APPI and GDPR Data privacy compliance under APPI and GDPR- (Japan) Clintask’s data privacy team supports Japanese companies in implementing privacy-by-design frameworks compliant with APPI and GDPR. Services include DPIA, consent management, and international data transfer compliance for global trial operations.
GxP compliance for Japanese CROs
GxP compliance for Japanese CROs GxP compliance for Japanese CROs- (Japan) Clintask’s bilingual experts assist Japanese CROs in aligning PMDA expectations with global GCP, GLP, and GMP standards. We implement CSA-driven validation, data integrity assessments, and QMS frameworks that support sponsor audit readiness for global trials.
CAPA and Quality metrics management
CAPA and Quality metrics management CAPA and Quality metrics management Clintask’s CAPA management framework ensures deviations and audit findings are addressed through structured root cause analysis and preventive controls. We establish automated tracking dashboards, enabling continuous improvement and transparent oversight for internal QA and sponsor audits.
Validation as a Service
Validation as a Service Validation as a Service Clintask offers Validation as a Service globally, ensuring continuous CSV, periodic review, and change control management. Our expert teams provide real-time validation documentation and audit support to meet regulatory and sponsor expectations.
QaaS – Quality as a Service
QaaS – Quality as a Service QaaS – Quality as a Service Through Clintask’s QaaS model, organizations access virtual QA experts who perform audits, CAPA management, inspection preparation, and QMS maintenance on demand. This reduces fixed costs while maintaining full compliance with GxP and data integrity standards.
Mock inspections & audit readiness
Mock inspections & audit readiness Mock inspections & audit readiness Clintask conducts mock inspections replicating FDA, EMA, and MHRA conditions to prepare sites for regulatory scrutiny. Our simulation programs identify documentation gaps, CAPA weaknesses, and staff training needs across clinical, laboratory, and manufacturing operations. We’ve supported over 150+ inspections worldwide, helping organizations build long-term inspection […]
FDA and NMPA compliance consulting
FDA and NMPA compliance consulting FDA and NMPA compliance consulting Our consultants help Chinese biotech and CRO companies align quality systems with both FDA and NMPA standards, enabling cross-border compliance. Services include CSV, GxP audits, and QMS integration supporting international sponsor partnerships.