Clintask Solutions provides GxP compliance services, including GCP, GLP/GCLP, CSV/CSA, cGMP, and PV.
We regulate audits to assess ensuring full regulatory compliance.
Our team identifies any potential gaps or risks that could compromise quality, safety, or regulatory compliance, providing you with actionable recommendations that align with industry best practices.
Investigator site (CROs/FSP) GxP gap assessments & Mock inspections CDM/PK and Biostatistics Systems & Internal processes(QMS) Pre-inspection readiness and Risk based assessments Good Clinical Practice protects trial participants and supports reliable clinical trial data.
Consult Clintask about Investigator site (CROs/FSP), GxP gap assessments & Mock inspections, CDM/PK and Biostatistics, Systems & Internal processes(QMS), Pre-inspection readiness and Risk based assessments. Support is tailored to the agreed scope and applicable requirements.
CRO/Vendor Study audits,Study Plans and Amendments Study report & Raw data Bio-analytical laboratory. Good Laboratory Practice addresses the organisation, conduct and reporting of non-clinical safety studies.
Consult Clintask about CRO/Vendor, Study audits,Study Plans and Amendments, Study report & Raw data, Bio-analytical laboratory. Support is tailored to the agreed scope and applicable requirements.
Vendor qualifications Gap assessments SOP development Good Clinical Laboratory Practice brings quality controls to laboratories supporting clinical trials.
Consult Clintask about Vendor qualifications, Gap assessments, SOP development. Support is tailored to the agreed scope and applicable requirements.
Qualification/Re-Qualification audits QMS compliance and Gap analysis For cause audits Vendor audits Good Manufacturing Practice addresses consistent production and control of medicinal products.
Consult Clintask about Qualification/Re-Qualification audits, QMS compliance and Gap analysis, For cause audits, Vendor audits. Support is tailored to the agreed scope and applicable requirements.
PV system PSMF SLA case processing compliance oversight RCA & CAPA Good Pharmacovigilance Practice supports the monitoring and assessment of medicine safety.
Consult Clintask about PV system, PSMF, SLA case processing compliance oversight, RCA & CAPA. Support is tailored to the agreed scope and applicable requirements.
GxP computerized system validations GxP IT consulting 21 CFR PART 11 compliance and Annex 11 compliance SDLC process Computerised System Validation evaluates whether a system performs as intended for its regulated use.
Consult Clintask about GxP computerized system validations, GxP IT consulting, 21 CFR PART 11 compliance and Annex 11 compliance, SDLC process. Support is tailored to the agreed scope and applicable requirements.
