Consulting:

* Full plant GMP audits along with comprehensive reports and suggestions on improving facilities to meet compliance with FDA GMP regulations and/or GMP certification programs (“audit readiness’)

* Full auditing of suppliers of raw materials and components

* Identification/remediation of GMP weaknesses and deficiencies
(gap analysis) to identify areas for improvement and create necessary documentation for a successful audit.

* In-house QA support

* Management of Corrective Actions and Preventative Actions (CAPA)

* Address nonconformances from FDA and GMP certification program audits, including FDA warning letters