Pharmaceutical Compliance Associates (PCA) specializes in compliance consultation relating to current Good Manufacturing Practice (GMP) regulations and Food & Drug Administration (FDA) requirements. Services offered by PCA include compliance audits and mock FDA inspections, establishment and implementation of quality assurance programs, development and review of validation studies, investigation and resolution of compliance and quality problems, compliance review of facilities and equipment design, and development and presentation of employee training programs.

PCA's consultation and training services are conducted by professionals with extensive compliance experience including prior employment with the FDA.

Compliance & Technical Audits:Internal GMP AuditsMock FDA InspectionsPre-approval (PAI) Inspection AuditsContractor AuditsAudit Program DevelopmentGMP Compliance EvaluationResearch and Development Compliance programs

Quality Assurance:Change Control SystemQuality Assurance ProgramsDocument Control SystemProduct Annual Review ProgramGMP & Technical Training ProgramsBatch Record Review SystemProcess Deviation InvestigationsProduct Failure InvestigationsBatch Release/Rejection Evaluation

FDA Compliance:Responses to FDA Letters & FD-483'sResponses to FDA Regulatory ActionsCorrection of FDA ObservationsRepresentation at FDA Meetings

Validation:Design of Validation StudiesReview of Validation Protocols & ReportsValidation Data Review

Facilities:Compliance Review Of Facilities & Equipment DesignCoordination for FDA Review & Approval