Our Services

FDA Readiness & Response:

  • Prepare for an FDA Inspection (PAI/Post Approval GMP/For Cause)
  • Respond to FDA 483 observations
  • Respond to FDA Warning Letter

Quality System Services

  • Develop or Revise your Standard Operating Procedures (SOP).
  • Developing a comprehensive and effective CAPA program
  • Batch Record Reviews
  • Develop SOPs 
  • Establish Quality Metrics Program
  • Self-assessment and internal audits
  • Suppler Audits
  • Data Integrity Assessment

GMP Training – Learning & Development

  • Conduct GMP & Technical Training
  • Conducting Effective Deviation and Laboratory OOS Training
  • Data Integrity Training
  • QA and Laboratory Training

Continuous Improvement Projects

  • Process Validation and Process capability projects
  • Lean and six-sigma projects

 To learn more and to get a free quote, please contact us today.

Phone: (267) 334 5722 | Email: Contact@gmpscientific.com