Innovation Commercialisation Program
Transform product concepts into compliant, scalable innovations through feasibility, prototyping, and regulatory-aligned development.
Overview
Innovation to Commercialisation Program supports brands in transforming scientific and technical concepts into compliant, market-ready products. From early-stage feasibility and regulatory risk analysis to development guidance and launch alignment, the program embeds execution foresight into every phase of innovation.
Structured Journey to Compliance
Built to guide every step with clarity, speed, and regulatory precision - from planning to execution.
Market & Regulatory Assessment
Analyse target market trends, applicable regulatory classifications, and category-specific challenges.
Ingredient Feasibility Review
Evaluate ingredient acceptability, restrictions, and pre-approval status based on regional regulations.
Compatibility Evaluation of Active & Inactive Ingredients
Assess chemical, functional, and regulatory compatibility between components in the intended formulation.
Pre-Formulation Studies
Conduct trials to determine stability, solubility, and potential interactions of selected ingredients.
Finalization of Paper BOM
Establish the complete technical formulation, listing all components with defined specifications.
Pre-Formulation Studies
Prepare small-scale batches to validate formulation performance and process parameters.
Physio-Chemical Property Testing
Assess key properties such as pH, viscosity, dispersion, and appearance for initial quality benchmarks.
Pilot Batch Manufacturing
Execute limited-scale production runs to simulate commercial manufacturing conditions and process scalability.
Analytical & Stability Testing
Conduct validated analytical testing and ICH-compliant stability studies to establish product shelf life.
Safety & Efficacy Review
Evaluate the safety and performance profile through clinical data review or documented claims substantiation.
Manufacturing Feasibility Assessment
Ensure formulation and process compatibility with identified CDMOs or manufacturing partners.
Packaging Feasibility Evaluation
Assess packaging formats for compatibility, stability, regulatory compliance, and cost efficiency.
Add on Services
Contract Manufacturing
Connect with vetted manufacturing partners to scale your formulation into compliant commercial batches
Regulatory Support for Technology Transfer & Loan Licensing
Navigate tech transfer and licensing with regulatory alignment across CDMOs, CMOs, and local partners
Technical & Scientific Support
Access expert input on formulation, testing protocols, and technical documentation to support smooth scale-up
Manufacturing Site Qualification
Assess and qualify manufacturing facilities to ensure regulatory, quality, and capacity readiness.
Our USP
Engagement Flexibility
Outsourced-Based Model
Pilot-to-Scale Execution
- Full execution ownership - from feasibility to launch readiness
- Coordination with third-party labs, certifying agencies, and manufacturing partners
- Ideal for companies seeking an end-to-end solution with minimal internal load \
- Ensures speed, compliance, and centralized accountability across stakeholders
Scope-Based / Project-Based Model
Structured Execution Model
- Engagement based on defined service phases (e.g., formulation feasibility, pilot testing, launch prep)
- Fixed deliverables and timelines for each selected phase
- Ideal for companies with in-house capabilities looking to plug specific regulatory or technical gaps
- Expandable into adjacent scopes like packaging, claims, or CDMO coordination as needed
Our Global Presence
Proven Impact. Precision in Execution
Accelerated product readiness through compliance-aligned development, technical validation, and seamless transition from lab to launch.
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.
Make your next innovation launch-ready from day one.
Avoid costly pivots. Design for compliance. Build boldly. Regnova’s Innovation Commercialization Enablement program keeps your innovation moving at market speed.
