TRHC effectively crafts regulatory and medical strategies that lead products through the regulatory clearance/approval process (as well as other global regulatory agencies), successfully launching products and monitoring post-market product performance through surveillance. New product value is maximized by providing early stage strategic input to develop superior and differentiated products that have proven real-world medical and economic value preferred by patients and healthcare providers. At the same time, TRHC applies best-in-class quality management system processes throughout the product development lifecycle that meet ridged international standards.
The Regulatory and Medical Science department supports product development and commercialization by applying state of the art technical, quality, and clinical evidence processes that meet or exceed expectations for safety, efficacy, quality, and performance of all regulated products.
Specific functions of the department include:
- Providing scientific, medical, and regulatory expertise and guidance in interpreting government regulations, product performance, unmet medical needs, clinical evidence gaps and internal policies
- Developing, directing, and leading the timely implementation of regulatory and medical business plans for product releases and updates into U.S. and international markets
- Delivering optimized regulatory and medical strategies for life-cycle management that sustain medical and economic value
- Integrating with the quality management system, assuring that the product development lifecycle conforms to local and global regulatory requirements
- Creating and implementing medical plans using best-in-class medical communication practices that enable the safe and effective use of TRHC’s marketed products
- Building, maintaining, and managing effective professional peer-peer relationships with external experts, advisors and key opinion leaders through scientific/clinical exchange communicating product value and assessing unmet product needs
- Directing the assessment and improvement of key business processes to ensure compliance with current and future regulations