GXP Quality & Validation Services

GXP QUALITY & VALIDATION

Being compliant and being in compliance can mean entirely different things. Advanced Clinical GXP Quality Services guide our clients through global regulatory changes while helping them avoid crippling fines and delays caused by non-compliance. Our support allows industry professionals and project managers to optimize their time and dedicate their resources to the clinical and manufacturing tasks necessary within the Medical Device, Pharmaceutical and Biotech Industries.

Our team of industry-leading experts is uniquely qualified to support a variety of initiatives, including:

  • Project-specific quality planning
  • Fully outsourced quality infrastructure engagements
  • Project support through individuals and specialized teams, or as the project requires

Quality

Advanced Clinical offers a customized and scalable suite of services, including:

Audits

  • Systems
  • Documents
  • Vendors

Infrastructure Support

  • Quality Planning
  • SOP Development

Specialized Consulting

  • Response to FDA Guidances
  • Gap Analyses
  • Inspection Readiness
  • Risk Management

Audits

  • Systems
  • Documents
  • Vendors

Infrastructure Support

  • Quality Planning
  • SOP Development

Specialized Consulting

  • Response to FDA Guidances
  • Gap Analyses
  • Inspection Readiness
  • Risk Management

Validation

Advanced Clinical provides consulting and staffing services across the full lifecycle of validation. Validated systems are critical to avoid FDA 483 letters and financial penalties. Advancements in technology fuel the need for more efficient analytic systems, increasing the complex responsibilities of ensuring these systems are validated.

Whether large or small in scale, Life Sciences systems play an equal role in supporting a successful clinical trial. Collaborating with an experienced partner is critical to successful validation. Advanced Clinical’s team of experts, including our pipeline of readily available consultants, is prepared to support a wide range of validation compliance solutions and validation project staffing needs