Linda Sreshta

With over 30 years of experience in the pharmaceutical and biotechnology industries, I specialize in regulatory and scientific medical writing that supports the full spectrum of drug development—from early-stage research to global regulatory submissions. I bring deep expertise in authoring and managing critical documentation for INDs, CTAs, and global marketing applications across a wide range of therapeutic areas. I offer expert-level writing services including Briefing Packages, General Investigational Plans, Clinical Overviews, Integrated Summaries of Safety and Efficacy, Pediatric Plans, Orphan Drug and Fast Track Designations, Protocols, Clinical Study Reports, and more. Sreshta Regulatory Writing: Trusted Expertise. Submission-ready results.