Overview
Structured Journey to Compliance
Built to guide every step with clarity, speed, and regulatory precision - from planning to execution.
Add on Services
Our USP
Engagement Flexibility
Our Global Presence
Proven Impact. Precision in Execution
Launch right with Regnova
From compliance to commercial success we’ve got you covered.
Frequently Asked Questions
Our modular model supports scale - from single product surveillance to portfolio-wide coverage, with options to expand to new geographies.
Yes, we reconcile safety data from multiple sources and consolidate it into regulator-ready PSURs, PBRERs, or PMCFs with narrative support.
We build tailored SOPs, integrate root cause tools (e.g., Ishikawa, 5-Why), and align the process to your product class and geography.
We handle case intake, evaluation, and submissions to systems like MedWatch, EudraVigilance, and PVPI -ensuring format and timeline compliance.
Yes ,our program is structured to support both pharma (AE case management, PBRERs) and devices (PMCF, trend reports) through a unified framework.
Yes ,we assess packaging feasibility for compliance and stability, and we review claims for regulatory alignment and substantiation.
No problem. The program is modular - you can engage for pilot batch execution or any other defined phase independently.
Absolutely. Through our partner lab network, we coordinate analytical, stability, and safety testing as part of the launch preparation process.
Yes, we conduct region-specific ingredient reviews to assess acceptability, regulatory status, and associated risks across target geographies.
This program is designed to support both early-stage concept development and post-formulation refinement. The earlier you engage, the more aligned your product will be with regulatory and market expectations.
Yes - the program is fully modular. You can choose specific steps based on your internal readiness and regulatory needs.
Timelines vary by product type and market, but most projects are completed within 6-9 months, which is 15-20% faster than standard industry timelines.
It’s built for both. Whether you're entering a market for the first time or expanding your footprint, the program adapts to your regulatory maturity and market goals.
Regnova or its channel partners can act as MAH or legal representatives, ensuring full compliance without needing a local entity.
Unlike traditional advisory models, this program offers end-to-end execution -from feasibility assessment to dossier submission and MAH support -with built-in speed and regional alignment.
