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Specializing in Pharmacopeial Compliance

CompendAlign™ Program

With the CompendAlign™ program, our team will conduct a thorough gap assessment of your analytical test methods, SOPs, and specifications with the goal of understanding what is required to ensure compliance with pharmacopeial standards. From the gap assessment, we will propose an action plan to resolve observed gaps with the end result being full compliance.

CompendAssure™ Program

This program includes all aspects of the CompendAlign™ program but goes further to ensure your continued compliance with pharmacopeial standards by conducting gap assessments against new or revised compendial standards on an ongoing basis. By implementing CompendAssure™, you can ensure full compliance prior to the intended effective date of the new/revised articles.

Looking for Assistance with Other Quality Systems? Let Us Handle the Work

Our extensive experience and continuous personal development ensures that we are proficient in the following:

  • Out of Specification (OOS) Investigations
  • Quality System Implementation
  • Project Management
  • Manufacturing Deviation Investigations
  • Project Management
  • QC Laboratory Efficiency Assessments/Improvements
  • Data Integrity Assessment
  • Computer System Validation/Data Migration Plans/Decommissioning Plans
  • Instrument Qualification (DQ/IQ/OQ/PQ)
  • Complaint Investigations
  • Annual Product Reviews
  • LIMS and Chromatography Data Acquisition System Implementation/ Upgrades 
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