Quality Management System
At NCP, our extensive Good Pharmacovigilance Practice (GVP) solutions demonstrate our dedication to patient safety. We carefully track, document, and evaluate all safety data to guarantee GVP complies with legal requirements and public health is safeguarded. Pharmacovigilance audit procedures that adhere to strict regulatory requirements are used by the Quality Assurance team. In accordance with internal SOPs, GVP regulations, and GVP compliance, our skilled auditors, who have undergone numerous health authority inspections, perform recorded risk assessments.
NCP provides pre-designed risk assessment methodology that can be modified to satisfy particular customer needs. The documented Risk-Based Audit Plan, which is developed based on the evaluation of risk factors as specified in the strategic audit plan, is followed while planning the various audits. Our certified auditor’s conduct and successful delivery have given them extensive experience in recent years. We are flexible and adaptive, using our wealth of expertise and experience to help you.
SERVICE OFFERINGS
MOCK INSPECTIONS
BUSINESS PARTNER AUDITS
MOCK INSPECTIONS
Mock Pharmacovigilance (GVP) Inspections conducted remotely for readiness of future inspections. Qualified team with face-to-face PV inspection handling exposure includes EMA, MHRA, ANSM, BfArM, AEMPS, USFDA, DCGI and TGA.
RISK ASSESSMENT
BUSINESS PARTNER AUDITS
MOCK INSPECTIONS
Risk-based Audit Planning (strategic, tactical and operational) and Audit Program Management.
BUSINESS PARTNER AUDITS
BUSINESS PARTNER AUDITS
BUSINESS PARTNER AUDITS
Includes audits of cross-licensing, co-licensing, local affiliates, local MAH, local QPPVs, service providers/vendors, technical service providers/database Audits, distributors/manufacturers, etc. partners, with having proven track record of 100+ audits conducted in last two years.
SYSTEM AUDITS
GAP ANAYLYSIS & IMPACT ASSESSMENT
BUSINESS PARTNER AUDITS
System Audits of end-to-end pharmacovigilance activities, cross-functional/associated areas to Pharmacovigilance and client specific activities.
VENDOR ASSESSMENTS
GAP ANAYLYSIS & IMPACT ASSESSMENT
GAP ANAYLYSIS & IMPACT ASSESSMENT
Due diligence on behalf of a client in the process of acquiring a new vendor.
GAP ANAYLYSIS & IMPACT ASSESSMENT
GAP ANAYLYSIS & IMPACT ASSESSMENT
GAP ANAYLYSIS & IMPACT ASSESSMENT
Gap analysis to identify areas for development and offer practical suggestions to maximize your pharmacovigilance activities by implementing mitigation strategy.
SOP DEVELOPMENT
QMS DEVELOPMENT & CONSULTANCY
QMS DEVELOPMENT & CONSULTANCY
GxP SOP Development & Gap Analysis. New and revised SOP creation and review.
QMS DEVELOPMENT & CONSULTANCY
QMS DEVELOPMENT & CONSULTANCY
QMS DEVELOPMENT & CONSULTANCY
Assess the effectiveness of your quality management system and developing the QMS on behalf of client.
COMPLIANCE MANAGEMENT
QMS DEVELOPMENT & CONSULTANCY
COMPLIANCE MANAGEMENT
Provides deep expertise in regulatory compliance across various standards including client oversight management activities.