In this evolving environment of regulatory vigilance, it is important to be prepared for inspections by global authorities at any time.

Pharmatek Solutions experts will work with you to develop strategies, plans, and tools to navigate this changing inspection environment. We aim 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 lifecycle of your therapy.

Our agile inspection preparation process is based on industry-leading practices and decades of experience. In the event of a regulatory authority inspection, your team will have a plan in place, and we can be an additional resource to assist with the inspection and responses to inspectors.

Our range of Inspection Readiness services include:

Mock Inspections

SME readiness

Strategic planning

• • Training
  • Key document readiness

Response and Remediation

Postmarketing Adverse Drug Experience (PADE) Compliance Program