Expert Regulatory Writing Services
Trusted expertise.
Submission-ready results.
About Sreshta Regulatory Writing
Proven Professional
Diverse Therapeutic Areas
Diverse Therapeutic Areas
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.
Diverse Therapeutic Areas
Diverse Therapeutic Areas
Diverse Therapeutic Areas
Oncology ( solid tumors, hematologic malignancies, immuno-oncology, antibody-drug conjugates), metabolic diseases (diabetes, obesity), rheumatology, infectious disease (bacterial and viral), CNS, cardiovascular, respiratory ( asthma, COPD ), hematology, dermatology, and urology.
Submission-ready Results
Diverse Therapeutic Areas
Submission-ready Results
I offer confidential, expert-level writing services including Briefing Packages, General Investigational Plans, Clinical Overviews, Integrated Summaries of Safety and Efficacy, Pediatric Plans, Orphan Drug, Breakthrough and Fast Track Designations, Protocols, Clinical Study Reports, and more.