WELCOME TO PARADIGM AUDITING AND CONSULTING
WHO ARE WE?
Paradigm Auditing and Consulting is a reliable and professional Quality Assurance (QA) Auditing and Consulting company that offers a full range of Quality Management System, GCP, GVP, GMP and GLP services on a local or global basis.
OUR SERVICES
QUALITY MANAGEMENT SYSTEM
Paradigm Auditing and Consulting has a team of highly experienced and knowledgeable consultants who can evaluate and provide effective solutions in various aspects of the client’s Quality Management System (QMS). These services include but not limited to:
- Development of new QMS or assessment of current systems
- Development of new SOPs or gap analysis of existing procedures
- Development of risk-based audit programmes
- Development of CAPA management system
- Development of training system and provision of GXP training
PHARMACOVIGILANCE SYSTEMS
Paradigm Auditing and Consulting has a team of professional consultants in the pharmacovigilance (PV) area that can provide expertise to support the development and improvement of the client’s pharmacovigilance system covering the full lifecycle of the products.
AUDITS
Paradigm Auditing and Consulting has a team of professional and highly experienced consultants who can conduct audits of GXP activities to ensure compliance to the client’s business and regulatory requirements. Services include but not limited to:
- Investigator site audits,
- Vendor audits,
- Business partner audits,
- Document audits,
- Systems and process audits etc.
INSPECTION READINESS AND SUPPORT
Paradigm Auditing and Consulting provides support in all aspects of inspections from pre-inspection preparations to hosting and post-inspection response and CAPA management
DUE DILIGENCE
Paradigm Auditing and Consulting offers expertise in supporting the client’s due diligence activities, from assessing the quality of the clinical trials in an in-licensing deal to providing risk advice to companies.
WHY CHOOSE PARADIGM AUDITING AND CONSULTING?
At Paradigm Auditing and Consulting, we have a professional team with extensive global experience and yet with strong local knowledge. The client can rely on our team to provide quality services and be assured that all activities are performed at the highest standard of integrity. Clear communication will be maintained throughout all stages of the project ensuring that we have mutual understanding of the requirements and the project status.