Product Development

We create and manage comprehensive domestic and global product development programs for biotech, pharmaceutical, and medical device products on behalf of our partners. The programs cover all aspects of development including scientific, medical, clinical, regulatory, toxicology, manufacturing, patent review and market assessment.

Through our core RRD development teams and our extensive network of expert affiliates, academic consultants, and preferred service partners, we offer our clients exceptional product development support covering preclinical through product approval in the following areas:

• Strategic planning
• Protocol design including collateral study materials
• Project management
• Clinical trial management
• Regulatory affairs support including preparation of FDA submissions
• Preparation for all types of FDA meetings including FDA Advisory Panel meetings
• Biostatistics and data management
• Data analysis and report preparation
• Chemistry, manufacturing and controls
• Quality systems support including GCP/GLP/GMP audits, and SOP planning and development

How is RRD unique?