Quality Assurance

White-Salters Consulting can help ensure quality is built into your products by partnering with your team to provide the following support:

  • GLP/GMP/GCP Strategic Advice
  • SOP Development
  • Auditing – Vendors and Internal Systems
  • Review of Nonclinical and Clinical Protocols and Final Reports
  • Batch Records, Stability Data, and Validation Documentation Review and Approval
  • PAI Readiness Training

Regulatory Affairs

Let us partner with you to provide strategic and operational regulatory support for your drug development program in the areas of:

  • Regulatory Strategy Development
  • Submission Support
  • Type A, B and C Meeting Preparation/Management
  • Risk Management (RMP/REMS)
  • Orphan Drug Designation Assistance
  • Medical/Technical Writing

GXP Training

At White-Salters Consulting, we recognize that keeping staff appropriately trained and up-to-date with regulations at all times is challenging, especially when industry guidelines are evolving and changing constantly. As a consequence of experiencing difficulty with maintaining qualified staff, companies are often found to be noncompliant following an audit. We can help!