Consulting Services

Quality and Validation expertise customized to your needs

Advanced Clinical

A PROVEN PARTNER TO ENSURE REGULATORY COMPLIANCE

The engagement of an experienced partner is critical to successful product development and Advanced Clinical offers a full range of consulting and staffing services to support a variety of quality and validation initiatives.

QUALITY

Advanced Clinical recognizes that demonstrating compliance with regulatory requirements is the first and most essential element of quality management for our clients. Our team of former FDA consultants and compliance experts are readily available to support each unique situation.

Advanced Clinical specializes in:

  • Quality infrastructure engagements
  • Project-specific quality planning
  • Project support through individuals and/or specialized teams

VALIDATION

As technology advances, so too does the responsibility of ensuring that facilities, processes, and systems are fully validated. Advanced Clinical’s approach to validation and team of readily deployable consultants, are stringent on the regulations set forth by the FDA to produce products with the highest degree of assurance in meeting all the attributes they are intended to possess.

Advanced Clinical supports:

  • Project support through both individuals and specialized teams
  • Full lifecycle validation and verification engagements
  • System specific oversight and change management
  • Technology, risk, and gap assessments
  • Project staffing for both short- and long-term initiatives




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