Submission discipline built from repeated practice.
Rishi Biotech delivers regulatory affairs services and practitioner training across drug filings, pharmacovigilance operations, and medical device compliance — all structured around the workflows your organization actually runs.
Three operational pillars, no gaps.
Our regulatory services cover the full compliance surface: dossier preparation and submission management, end-to-end pharmacovigilance operations, and medical device technical file and CE/FDA pathway support.
Regulatory Affairs
Pharmacovigilance
Medical Devices
Technical file compilation, risk management per ISO 14971, MDR/IVDR compliance review, and 510(k) pathway documentation prepared against current guidance.
IND, NDA, MAA, and ANDA dossier preparation. Submission management, gap analysis, and agency correspondence handled against real filing timelines.
Adverse event intake, signal detection, PSUR and PBRER authoring, and SUSAR reporting — managed as a continuous operational process, not a project.
Compliance isn't a deliverable. It's the standard every filing is held to — and the standard every workflow we build is designed around.
Practitioners work inside real dossier structures.
Regulatory Affairs training places participants inside actual CTD module structures, live adverse event intake workflows, and device technical file templates drawn from current submissions.
Programs are structured for regulatory coordinators stepping into submission roles, PV associates taking on signal detection, and device compliance officers preparing first technical files. No hypothetical scenarios — only process-tested material.
Ready to reduce your regulatory risk?
Whether you need a submission team embedded in your filing cycle or a training cohort brought up to speed on PV operations, the engagement starts with one conversation.