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PAREXEL Consulting Alliance

Service Highlights

Integrated Expert Services:

Product Development and Regulatory Affairs

Clinical and Manufacturing Excellence

GxP Compliance and Risk Management

Product Development Strategy and Due Diligence Expert development strategy and technical evaluation for drugs, biologics, device/diagnostics, neutraceuticals, cosmeceuticals

Regulatory Strategy Consulting Successful regulatory development strategies that consider precedents, global requirements and best path to approval

CMC & Manufacturing Consulting Expert CMC technical evaluation, writing and documentation; independent evaluation of contract manufacturers

Nonclinical Consulting Expert assessment and optimization of nonclinical development programs and study designs; independent evaluation of laboratory testing services

Clinical Development Consulting (Phases I-IV) Innovative design of clinical development plans and clinical studies to support the best reguatory path to approval

Regulatory Agency Liaison and Issue Management Facilitation of agency communications/relations and highly responsive resolution of regulatory issues

Worldwide Clinical Trial Applications Strategy, design, execution and submission of worldwide clinical trial applications

Worldwide Marketing Applications Strategy, design, execution and submission of worldwide marketing applications, including electronic CTDs

Pricing and Reimbursement Consulting Expert research and advice on pricing and reimbursement strategies and implementation

Worldwide Labeling and Readability Services Single and multi-country/nation strategy and regulaotry review, mock-ups readability and user testing ; language translation services

Advertising and Promotional Material Compliance Review of advertising and promotional materials of new and exisiting products to meet changing regulations and maintain product revenues

Product Lifecycle Management Product extensions into new markets and indications, new formulations; out-licensing optimization