Compliance & Medical and Regulatory Affairs

Sustainable compliance is about more than ensuring employees are meeting regulations. It’s about embedding quality and accountability into everyday behaviors. We help organizations move beyond “check-the-box” training programs to build a culture where compliance is understood and embraced across all roles.

Including, but not limited to:

• Training aligned to GxP, FDA, EMA, OSHA, and ICH standards
• Interactive, scenario-based training experiences that build a compliance mindset through real-world practice
• SOP adoption and change management strategies
• Ongoing reinforcement tools to reduce errors and risks

Accurate, timely, and accessible scientific knowledge is essential to maintain internal alignment and readiness. We help build scientific expertise, credibility, and confidence across medical affairs teams and MSLs.

Including, but not limited to:

• Disease state and therapeutic area education for new indications and portfolio expansions
• Development of capability frameworks and core competency models for medical and regulatory affairs teams
• Advanced learning and upskilling programs for MSLs focused on scientific fluency, data interpretation, and storytelling
• Advanced scientific curriculums for MSLs and medical affairs teams

Navigating global regulatory environments requires more than documentation. It demands cross-functional readiness and process alignment. We empower regulatory teams to manage evolving global frameworks, submissions, and systems more effectively.

Including, but not limited to:

• Training and enablement of end-to-end submission processes
• Change management for new systems, processes, and technologies
• Cross-functional communications across regulatory, clinical, and quality
• Enablement and adoption of new regulatory technologies through just-in-time learning and process simulations

Responsible innovation during the product development process starts with cross-functional collaboration. We help break down silos between medical, regulatory, compliance, quality, and HEOR teams to increase insight sharing and efficiency.

Including but not limited to: 

• Collaboration frameworks and governance models
• Joint workshops and capability alignment
• MLR process optimization and shared learning
• Cultural integration across scientific and regulatory functions