Our Expert Team
Our Dedication
SKM Pharma Solutions is a leading consulting firm in the pharmaceutical and life sciences industry, providing comprehensive support for organizations dealing with copyright compliance, clinical operations, and regulatory submissions. With a team of seasoned professionals, we are committed to helping clients protect intellectual property, accelerate submissions, and maintain audit-ready documentation across all stages of drug development.
Our Specialized Services
Copyright Compliance Support
Clinical Operations Guidance
We offer specialized support for copyright compliance, ensuring that our clients navigate the complex landscape of permissions, licensing, and TMF management with ease. Our clinical operations guidance is designed to streamline processes and maximize efficiency for successful trial outcomes.
Regulatory Submissions Assistance
TMF Management
Our expertise extends to providing comprehensive assistance with global regulatory workflows and TMF management. We help organizations maintain audit-ready documentation and accelerate submissions, ensuring compliance and efficiency.
Medical Writing Support
Global Regulatory Workflows
SKM Pharma Solutions LLC offers meticulous medical writing support and expertise in global regulatory workflows. Our services are tailored to strengthen operational efficiency and accelerate submissions, ultimately contributing to the success of drug development through commercialization support.
Permissions and Licensing
Intellectual Property Protection
We specialize in permissions, licensing, and intellectual property protection, providing innovative solutions to mitigate copyright and compliance risks. Our focus on process optimization ensures that our clients maintain audit-ready documentation and achieve operational excellence.
Insights for Pharmaceutical Companies
Copyright Clearance Center (CCC) Industry Benchmark Report – Identifies widespread unauthorized internal sharing of articles within scientific and pharma environments and highlights that “the majority of literature use occurs before obtaining licenses or permissions.”
Unauthorized use of literature before permissions
McKinsey “Pharma M&A Integration Report.”
Notes that most companies significantly underestimate the volume and complexity of scientific content needing re-validation.
70% underestimation of repurposable literature volume during M&A
DIA (Drug Information Association) Regulatory Submissions Benchmarking Study.
Reports that third-party content errors and missing permissions are among the most frequent causes of submission delays.
Veeva “State of Submission Management in Life Sciences.” Confirms documentation gaps—including literature permissions—directly contribute to delay frequency.
50-60% of delays caused by permissions bottlenecks
TransPerfect Life Sciences Global Translation & Compliance Report. Notes that approximately one-third of translation errors in pharma materials originate from licensing or rights-related oversights.
30% of errors are related translation rights
Our Competitive Edge
1
End-to-End Support
Our end-to-end support is tailored to propel pharmaceutical and life sciences organizations forward, ensuring compliance, efficiency, and accelerated submissions.
2
Customized Solutions
We provide customized solutions that align with the unique needs of our clients, driving sustainable growth and success in the competitive pharmaceutical landscape.
3
Client-Centric Approach
Our client-centric approach is anchored in copyright, permissions, and licensing leadership—embedding rights expertise into partner workflows to deliver compliance clarity, mitigate risk, streamline operations, and translate complex challenges into measurable, sustainable value.
4
Innovative Strategies
We employ innovative strategies to address the complex challenges faced by pharmaceutical and life sciences organizations, driving efficiency and maximizing their potential.
Client Testimonials
"SKM Pharma Solutions LLC has revolutionized the way we navigate regulatory challenges and accelerate submissions. Their dedication to our success is truly remarkable."
Durata Therapeutics
"Charles is truly an expert on content rights issues, with extensive experience and knowledge of rights and rights/permissions issues. He was very helpful to me and my team in helping us solve permission issues involving use and re-use (and costs for same) of third-party content and images in our textbooks and media products."
Mary Carnis
"I have found Charles to be a highly dedicated and knowledgeable professional with expertise in permissioning, licensing, and negotiating with rights holders. He has the ability to read and understand complex concepts in copyright, documents, and agreements with the ability to distill them down to their essence, explain what the main issues are, and then offer practical and reasonable solutions."
Harold J. DelMonte, Esq.
