Shudarsana unifies Regulatory Intelligence, Literature Surveillance,PV Workflows, Technology and Systems into one immersive workspace.
End-to-end PV operations at audit-grade quality.
Global submissions, lifecycle management & intelligence.
CMC, batch docs, manufacturing compliance.
Risk-based GxP audits with full traceability.
ICSR intake, triage, narrative writing.
Compliance ready labels
"It's been more than 2 yrs and the service is improving day by day. Really great team support anytime."
"Team is always available to support and solve problems anytime. Even after office hours they are available for co operation. Their technology is awesome to use."
"The company always respect the team and the work, Not only they respect but also their work is very professional and clean."
"The rates of their service is too affordable and they are very supportive and very speedy to get the work done at any stage."
Expertise in designing as well as IT core and Business development along with technology development.
Expertise in Regulatory Affairs & Pharmacovigilance as well as other pharma domains with experience of more than 5 yrs
Dec 2025 On December 16, 2025, the USFDA released updated guidance regarding ANDA Submissions—Amendments and Requests for Final Approval to Tentatively Approved…
Read more ↗On Dec 11, 2025, the FDA announced a proposed order to add bemotrizinol (also known as Tinosorb S) to the OTC sunscreen…
Read more ↗Key Points: A new liquid infusion formulation of Remsima (infliximab) has been introduced in Europe as a 100 mg and 350 mg concentrate for…
Read more ↗