Inspection Readiness For Pharma and Life sciences Industry
The regulatory agencies of USFDA, EU has increased their alertness towards site inspection(s) of pharmaceutical, biotech and medical device industries. As a result, the number of inspections is steadily increasing year by year. In addition, these agencies have engaged in global capability building and training programs that have resulted in the creation of national inspectorates in Asia, Latin America, Africa and the Middle East.
The FDA is implementing a number of new programs designed to sharpen the effectiveness and timeliness of its regulatory, compliance, and enforcement systems. The agency established deadlines for industry to respond to significant inspection findings, which enable FDA to take enforcement action more rapidly if a company has not corrected violations documented after an inspection.
To address current scenario, Pharmatek experts develop strategies, plans, and tools to navigate the diverse, changing inspection environment and aims to help sponsors and CROs develop a culture and mindset that are committed to quality through proactive risk management, ensuring an inspection readiness state throughout the entire drug development life cycle.
Our agile inspection preparation process is based on industry-leading practices. Our experts will work with your management and process owners to identify inspection readiness gaps, define where necessary effective CAPA plans and oversee their timely implementation. In case of a regulatory authority inspection, we can bring an additional resource to support your organisation during the inspection and, if necessary, help with responses to the inspectors.
We perform inspection readiness evaluation of companies through the following.
- Mock Inspections
- SME readiness
- Strategic planning
- Key Document readiness
- Response and Remediation