About PC
Expert Services
Case Studies
News & Events
Careers
The Fusion of Expertise
Expert Services
Expert Bios
PAREXEL Consulting Alliance
Service Highlights
Integrated Expert Services:
Product Development and Regulatory Affairs
Clinical and Manufacturing Excellence
GxP Compliance and Risk Management
GMP, QSR, GCP, GLP Audits
GLP, GCP, GMP audits and assessments performed by appropriate specialists and former regulators
Inspection Readiness Consulting
Targeted education and support in preparation of a planned inspection including: Training, Quality System Assessment, Subject Matter Expertise Preparation, Mock Inspection, Onsite Inspection Support
Regulatory Risk and Crisis Management
Expert regulatory compliance risk aversion, responsive issue resolution, vacating of consent decrees, mandated expert consultant
FDA Communications Representation For Inspections and Enforcement
Insight and assistance with FDA communications and representation
Legal Liaison
Legal Liaison on internal compliance investigations, liaison to law firms
Corporate Compliance Governance Program Development and Integration
Integration and process optimization of GxP compliance with overall corporate governance programs
Safety/Pharmacovigilance
Comprehensive, risk-based, flexible solutions for the management of product safety and patient health during the entire lifecycle of a medicinal product
Clinical Compliance Strategy Consulting
Efficient risk based approaches to clinical operations that result in operational excellence and deliverables that can withstand regulatroy scrutiny
