PAREXEL Consulting | Law | Key Expertise Areas

Key Expertise Areas

Over 20 former regulators in the US and Europe; average of 25 years FDA experience amongst former FDA investigators.

IP/Product Development and Commercialization Strategies
Regulatory Liaison and Regulatory Affairs
Labeling and Promotional Compliance
Drug Safety/Pharmacovigilance Programs
Technology Transfer and In/Out-licensing Optimization
Compliance Strategies
Audits and Assessments
Inspection Readiness and Crisis Management Planning and Training
Prevention of FDA Enforcement Sanctions and Response to Agency Communications
FDA Crisis Management including Role of Expert Consultant
Risk Management and Mitigation Programs
Internal Investigations, Data Integrity Investigations, Application Integrity Policy issues
M&A and Strategic Alliance Evaluation and Integration
Due Diligence of Products, Development Plans, Regulatory Applications and Submissions, Partnerships, Suppliers

US: Vice President, Ron Kraus
Cell: 978-848-2634
E-mail: ron.kraus@parexel.com

International: Vice President, Paul Bridges
Cell: +44 (0) 1895 614956
E-mail: paul.bridges@parexel.com