Charles Morris

Founder and Principal

Charles Morris is a seasoned leader in copyright, permissions, and licensing with over 20 years of experience supporting publishing, education, nonprofit, and life-sciences organizations. As Founder and Principal of SKM Pharma Solutions, he helps pharmaceutical and life-sciences teams reduce copyright risk, ensure regulatory compliance, and scale compliant use of third-party content across research, development, and commercialization. Charles has led global rights programs, negotiated complex licensing agreements, and implemented rights-management systems. He holds an MA in Law and Governance (Intellectual Property) and a BS in Management Information Systems.

Cynthia Hadley-Morris

Cynthia is a seasoned Regulatory Affairs and Operations leader with more than 30 years of experience supporting biotechnology and pharmaceutical organizations. She specializes in regulatory submissions, eCTD, eTMF and RIMS implementation, inspection readiness, SOP development, and continuous process improvement across U.S. and EU regulatory environments. Her expertise includes Medical, Legal, and Regulatory (MLR) review and submissions, PADER reporting, and commercial support for adverse events and other post-marketing reporting requirements. Cynthia has led and supported over 130 IND, NDA, MAA, CTA, and post-approval submissions and is known for building scalable, inspection-ready regulatory and quality infrastructures.