Regulatory Support

Our regulatory consulting staff, many of whom serve on FDA, EPA, OECD, and WHO advisory panels and hail from previous senior-level positions within industry or government, can play a key role on any project and provide support during both preclinical and clinical development, product licensing, and regulatory approvals. Areas of expertise include pharmaceuticals, biologics, medical device, veterinary medicines, biocides, and cosmetics.

Services

• Development and registration strategies
• Data review, gap analysis, and strategic advice
• Documentation and presentation coaching
• Expert report preparation
• Clinical trial applications and trial support services
• Product license variations and defense
• Product life cycle management

What's New

Charles River and DSI to Co-Host Second Annual Safety Pharmacology Symposium and Workshop

Charles River Preclinical Services Announces Dates of 15th Annual Biotech Symposium

On-line Registration for the 2008 Charles River Short Course Now Available

All news items

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