Empowering Better Living Through Balanced Choices
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What’s Really Holding Pharmaceutical Back in Global Markets
Complex submission formats, inconsistent regulator expectations, and rising post-approval burdens aren’t just operational issues - they’re strategic risks. And most pharma teams aren’t set up to solve them.
Regulatory pathways vary widely - FDA, EMA, CDSCO, SFDA, and others all have different expectations and procedures.
eCTD, NeeS, or country-specific formats - each requires tailored documentation and constant rework.
Many countries mandate in-market representation and localized labeling - without them, submissions are blocked.
Post- approval demands include GMP, pharmacovigilance, safety updates, and labeling changes - all increasing in complexity.
New chemical entities, biologics, and Rx-to-OTC transitions face high scrutiny and uncertain outcomes.
Countries like China, Japan, and Saudi Arabia often require local data - slowing access and raising costs.
From dossier strategy to lifecycle compliance, Regnova partners with pharma brands to turn regulatory complexity into launch acceleration - across developed and emerging markets.
Tailored submissions for FDA, EMA, CDSCO, SFDA, PMDA, and more - including IND, ANDA, 505(b)(2), and centralized EU procedures
We manage filings, query responses, pre-submission meetings, and fast-track coordination.
Regnova offers country-specific regulatory insights, submission pathways, and label/claim validation to ensure your product is compliant before launch—especially useful for entering Asia, the Middle East, and emerging markets.
Act as your Marketing Authorization Holder or help appoint qualified in-country partners.
Handle renewals, variations, labeling changes, PV systems, and GMP compliance.
Guide reclassification, data alignment, and labeling strategy for profitable OTC transitions.
From gap assessments to CAPA implementation, we ensure your manufacturing partners meet GMP requirements across US FDA, EU EMA, WHO, and PIC/S frameworks - enabling inspection readiness and submission success.
Align local intelligence with global launch strategy across U.S., EU, APAC, and Middle East.
Whether you’re launching 1 SKU or scaling 10, Unlock India gets you compliant, retail-ready, and executing within 90 days.
Global Reach.
Network Driven.
Optimized in-store retail strategy across pharmacies, Watsons, Guardian, and modern trade—ensuring visibility, compliance, and conversion where it matters most.
End-to-end enablement for platform-native growth—optimizing listings, content, pricing, and performance across Shopee, Lazada, Amazon & more.
Full-funnel brand growth—from digital awareness to retail demand generation—with campaigns built to drive sell-through and market recall.
Integrated trade logistics with built-in compliance and SLA tracking—ensuring smooth movement of goods, on-time deliveries, and channel reliability.
Deploy on-ground teams to drive visibility, push activations, and monitor trade execution across priority outlets and pharmacy channels.
Real-time trade intelligence and performance dashboards—ensuring execution accountability, regulatory alignment, and faster GTM optimization.
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No problem. We can integrate into your existing structure or help validate your partner’s capabilities - and fill gaps with execution support if needed.
Yes. We design GTM strategies based on your category, product format, and positioning - covering D2C platforms, clinics, pharmacy retail, and distribution.
We support health, wellness, beauty, nutraceuticals, and consumer health products. This includes supplements, skincare, cosmetics, OTC, functional foods, and more.
Yes - and we’ve done it before. The 90-day timeline begins after regulatory approvals are secured and covers channel onboarding, GTM setup, and launch execution.
Timelines vary by product type and authority: CDSCO: 2–4 months , FSSAI: 1–2 months , AYUSH: 3–6 months. We begin execution planning in parallel to avoid delays.
No. Through our network of licensed importers and Market Authorization Holders (MAHs), you can launch in India without incorporating a local company. We handle this for you.
