Stories & Testimonials


Our accomplishments speak for themselves.  Below you'll find some project summaries

and testimonials from those who have worked alongside us.



Faced with a 483 warning letter on top of a long-standing consent decree,

a southern California company looked to Addis Pharma's primary consultant for help

 Addis co-founder, Yosief Mekonnen, spearheaded a monumental remediation project, guiding an LTS team to perform gap assessments on 150+ analytical test methods.  Overall, 140+ repeat/supplemental validation or verification studies needed to be performed to bring the entire product line into compliance.


"Yosief is very knowledgeable in both pharmaceutical compliance and analytical science.  He is also skillful in out-of-the-box thinking and problem solving . . . The project successfully met the tight FDA commitment timeline and helped the company lift the consent decree."

- Site Project Manager

"Professional, knowledgable, and trustworthy"

- Site Manager

"I really liked working with him, I learned a lot."

- Site Lab Analyst



Addis Pharma Wraps-Up Another Successful Remediation Project in Southern California

A team of consultants helped a client bring their analytical test methods for 54 products up to date with cGMP regulations.  Following a thorough gap analysis, nearly a hundred method validations or verifications were performed in under two years with just five consultants.  The team was able to complete the project ahead of schedule and under budget.  Another major project completed, another warning letter lifted; just an average day in the office for Addis consultants.

  



  

  

  


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