Scientific and Medical Affairs Advisory Group

Having both scientific expertise and a strategic mindset early in the development of an asset is paramount to succeeding in today’s competitive environment. The Scientific & Medical Affairs Advisory is Syneos Health^® Consulting’s dedicated group of highly adept consulting strategists specializing in Medical Affairs, Regulatory Affairs, and Quality & Compliance. These three areas are critical to the biopharmaceutical development and commercialization process, so we have developed teams of thought leaders and industry influencers with real-world experience whose unique combination of scientific and technical skills are grounded in a strategic mindset. 

As a global team working closely with both clinical and commercial disciplines within Syneos Health, we can prepare an asset or organization earlier in the process and across the entire life cycle, proactively planning, anticipating and predicting customer needs. Most importantly, we not only create strategic solutions, we have the unique ability to implement those solutions in the real world.

From guidance on improving customer interactions in Medical Affairs and assisting in product development and life cycle management to accelerate regulatory approval, to ensuring customers are truly in control of Quality Management Systems, we have developed the most comprehensive set of solutions to address any customer needs across the following services:

規制

• Advice, guidance and intelligence
• Strategic regulatory pathways and product development planning
• Accelerated pathway and fast track development and advice
• Pediatric plans and orphan drug strategy
• Strategic regulatory agency meetings
• Publishing and electronic submissions and maintenance

メディカル・アフェアーズ

• Global Medical Affairs Transformation & Operational Excellence
• Establishment of CoE Functions (Field Medical, Launch, Evidence Generation, etc.)
• Asset-specific Strategic Medical Foundation
• Medical Affairs Strategic Integration with Clinical Development
• Effective and Compliant Medical Affairs – Commercial Interface Models
• Value Demonstration and Metrics

Quality & Compliance

• Quality management assessment, refinement and redesign
• SOP writing and/or simplification
• Risk-based audit strategy
• Defining effective KPIs
• Mock inspection
• Training program design and rollout
• Corrective action and preventative action process and management
• Investigator training
• Regulatory compliance

Our Scientific & Medical Affairs Advisory team is the only one in the industry capable of developing standalone and integrated solutions that can lead to greater commercial success – maximizing the potential of your asset, portfolio of products, and your evolving organization.