Indivirtus – CRO Offers Real Time Cost Effective Solutions.

Good CSV and GxP can help you reduce CAPA, change control, batch recall and give good peace of mind to shareholders. Data Integrity, Security, Patient safety and Product Quality is the key. Qualification and Validation are integral steps in building quality into any facility. With over 27 years of professional expertise, we provide an efficient and effective documentation system that meets the requirements of International Regulatory authorities.

Our team of experts can manage development and implement entire Validation program for its Customers. We offer following services:

  • GAP Assessment audits / Due Diligence Audits
  • Vendor Assessment Audits
  • Reduction of Operational Redundancies in Manufacturing & Quality Control
  • Production Process Integration, Process Optimization & Yield Improvement
  • CAPA, OOS and risk management with appropriate mitigation and contingency plan
  • Managing Regulatory response & Remediation activities (USFDA & EU)
  • Implementation and monitoring of Quality Systems compliance based on FDA's six quality systems approach
  • People development through training and demonstration
  • Health Hazard Evaluation
  • PLC Validation
  • CSV Validation
  • Equipment Qualification
  • HVAC & Clean Room Validation
  • Compressed Air Validation
  • Calibration
Our Clients: