LDT can lend its experience and expertise to access your organization’s compliance and regulatory readiness. Knowing where your program’s weaknesses are can be the first step in developing an action plan to address your developmental needs.

LDT can conduct various types of Gap Analysis to assist in this developmental process:

  • cGMP (Current Good Manufacturing Practices / 21 CFR)
    • 503A & 503B (including all FDA regulatory guidance documents)
  • Pharmaceutical Compounding – Nonsterile Preparations <USP 795>
  • Pharmaceutical Compounding – Sterile Preparations <USP 797>
  • Handling of Hazardous drugs in healthcare settings <800>
  • DEA Regulation & Compliance
  • State Board of Pharmacy Inspection Readiness
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