Shadle Consulting Services
Good Science is Good Compliance
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::  Auditing  ::  Internal  ::  Suppliers  ::  Contract Manufacturers  ::  Contract Laboratories  ::  Inspection Readiness Training  ::
 
We have experience in performing audits to ensure contractors meet YOUR business and regulatory expectations.
  • Experienced auditors of raw material suppliers, API, contract manufacturers, test laboratories, and potential joint venture partners
  • Fluent in German; ready to perform audits for you in Germany, Austria, Switzerland,  and many other European countries.
  • Experienced in etiquette and social expectations in Asian countries. 
  • We can execute an audit on your behalf, or lead members of your organization on an audit.
  • Send your development scientist along as a subject matter expert; we train them while auditing.
  • We identify strategic challenges, recommend solutions, and facilitate communications with your suppliers. 

 

::  Inspection Readiness and Training  ::
We can perform a mock inspection to prepare your staff for FDA, EMEA, or other regulatory authority.
  • Staff development using a variety of scenarios.  Group training and one-on-one interview practice.
  • Post inspection review and management summary.
  • Review of inspection SOP and document readiness.
  • Logistical basics and audit etiquette, plus many other technical and non-technical aspects of an inspection.