LSPediA LLC, a leading software and service provider for the pharmaceutical industry, today announced an agreement with Catalyst Pharmaceuticals, a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating neuromuscular and neurological diseases. LSPediA will provide serialization services and software to Catalyst in order to comply with DSCSA regulations.
To meet the needs of its customers, Catalyst relies on a frictionless supply chain and close interaction with contract manufacturing organizations (CMOs), third-party logistics providers (3PLs), and technology vendors. By leveraging LSPediA’s Serialization Toolkit and consulting services, Catalyst will benefit from:
- Industry best practices around serialization implementation
- DSCSA-compliant Standard Operating Procedures
- CMO quality agreements and the publishing of CMO serialization specs
“We truly see this work as a partnership with Catalyst in their journey toward serialization compliance,” said Riya Cao, LSPediA CEO. “There are so many moving parts to this process—from labeling and packaging, to data exchange issues and vendor management—and we know how to work within all those elements and teams and become an agent of change and a driver of success. And our goals for Catalyst go beyond serialization and compliance: We want to improve how they deliver high quality medicine to their patients, and empower the company to be better positioned for the future, whatever that may bring.”
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), congenital myasthenic syndromes (CMS), MuSK antibody positive myasthenia gravis and infantile spasms. Firdapse® has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LEMS and Orphan Drug Designation for LEMS, CMS and myasthenia gravis. Firdapse is the first and only approved drug in Europe for symptomatic treatment in adults with LEMS.
About LSPediA – Life Sciences Solutions
LSPediA is a leading provider of enterprise software and services designed for pharmaceutical manufacturers, wholesale distributors, and dispensers. With LSPediA, customers can better implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates.