Our Projects
Inspection management and remediation
INSPECTION READINESS
First SOLVO concept – Inspection DocumentationSite Opening PresentationInspection Do’s and Don’tsHot Topics and back up action plansSenior Management mentorship for inspectionWhere other companies made mistake?Your Legal rights in inspection process
FRONT ENDING WITH REGULATORY AGENCIES
Help companies to set up meeting with AgenciesPrepare Face to Face (FtoF) meeting presentation – Depicting compliance statusPrepare the team for F to F meeting
RESPONSE TO OBSERVATIONS
Interpretation of observations with inspection front room teamDefining response strategy to address observation comprehensivelyDrafting the response, cover letter and executive summaryCrafting response updates to agency
REMEDIATION SERVICES
Craft Remediation Master PlanSustainability Efforts for All time inspection readinessBuild Culture of QualityDraft Quality Improvement PlanDMF and ANDA Review for Accuracy and completenessPQA and DI reviewsYour Legal rights in inspection process