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About Regallience

Welcome to Regallience, India’s premier regulatory consulting firm dedicated to simplifying compliance, licensing, and market access for global and domestic healthcare, beauty, and wellness brands.

At Regallience, we do not merely process administrative filings—we strategically manage your regulatory risk. Navigating the complex frameworks of the Central Drugs Standard Control Organization (CDSCO) and State Licensing Authorities (SLA) under the Drugs and Cosmetics Act, 1940, Cosmetics Rules, 2020, and Medical Devices Rules, 2017 requires absolute precision.

Whether you are importing global luxury cosmetics, establishing a local manufacturing plant, or launching innovative medical devices, Regallience serves as your strategic local partner. We handle the legal red tape so you can focus on building and scaling your brand.

Why Choose Regallience?

 

Proven Filing Success

Successfully guided thousands of product registrations and statutory
approvals across cosmetics and medical device categories.

360° End-to-End Solutions

Established an all-inclusive compliance model spanning
Authorized Indian Agent (IAA) representation,
Device Master File (DMF) compilation,
SUGAM / MD Online Portal execution, and
NABL-accredited sample testing coordination.

Zero-Friction Market Acceleration

Maintained an industry-leading record in mitigating customs
freezes, port hold-ups, and discrepancy queries through
proactive, multi-tier pre-screening.

Comprehensive Licensing Coverage

Successfully secured Own Premises Licenses (Form COS-8 / Form MD-5/9),
Loan Licenses (Form COS-9 / Form MD-6/10), and Import Certificates
(Form COS-2 / Form MD-15) for brands ranging from emerging startups
to Fortune 500 enterprises.

Our Mission

Our mission is to empower life sciences, personal care, and med-tech companies worldwide with a transparent, predictable, and seamless path to the Indian market.

We bridge the gap between global brand ambition and intricate government compliance by delivering high-precision technical dossier management, labeling validation, and SUGAM/CDSCO portal execution at an optimized, business-friendly investment.

Our Vision

To be the world’s most trusted regulatory conduit for India’s healthcare and personal care sectors.

We envision an industry ecosystem where zero-error compliance accelerates global innovation, protects consumer safety, and drives sustainable growth across domestic manufacturing and international trade.

About the Founder

“Compliance should never be a bottleneck to global innovation. It should be the strategic foundation upon which brands build trust, protect consumers, and achieve sustainable market leadership.”

Anuj Kumar

Founder & Principal Regulatory Strategist, Regallience

As a Multidimensional Regulatory Affairs Professional, Anuj Kumar established Regallience with a singular vision: to bring clarity, velocity, and corporate structure to the complex world of statutory compliance and market authorization.

With deep domain expertise in navigating the evolving legal frameworks of the Central Drugs Standard Control Organization (CDSCO) and State Licensing Authorities (SLA), Anuj specializes in transforming intricate government mandates into predictable, business-friendly pathways for healthcare, med-tech, beauty, and personal care brands.

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