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RIAR
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About RIAR Consulting

Regulatory expertise and manufacturing intelligence for regulated industries

RIAR Consulting is a global regulatory consulting and manufacturing intelligence company supporting pharmaceutical, biotechnology and other regulated life-sciences organisations.

Book an exploratory call Our services
key authorities
5
core capabilities
6
named lead per file
1
minute exploratory call
30
Who we are

Our approach

Our work spans regulatory strategy, product registration, technical documentation, compliance and market access, alongside manufacturing intelligence solutions designed to improve operational visibility and help identify potential manufacturing risks.

We bring together regulatory professionals, scientific expertise and technology-driven capabilities to address challenges across the product and manufacturing lifecycle.

We combine regulatory understanding with technical and operational insight, helping organisations address compliance requirements while strengthening visibility into manufacturing processes.

Our story

Our mission

To help regulated industries navigate complex regulatory environments and make more informed manufacturing decisions through scientific expertise, structured regulatory execution and continuous manufacturing intelligence.

  1. March 2018

    Founded RIAR Consulting

    RIAR Consulting was founded by a team of five international regulatory consultants, initially specialising in US FDA submissions across pharmaceuticals, medical devices, and emerging nicotine technologies.

  2. February 2020

    Global expansion

    We expanded into the UK and EU regulatory markets, growing our team of expert consultants across multiple regulatory domains, including MDR, MHRA, PMTA, and quality management systems.

  3. October 2023

    Expanded global reach

    Our services broadened to support global registrations with leading authorities such as EMA (Europe), TGA (Australia), HPRA (Ireland), and HSA (Singapore), enabling clients to achieve faster, multi-market regulatory compliance.

  4. June 2025

    Expanded global presence

    RIAR Consulting opened our office in India and expanded operations across 16+ countries, supporting 100+ global clients with a network of top-tier consultants delivering high quality regulatory and compliance solutions worldwide.

“With deep regulatory expertise and structured execution, we help clients navigate approvals with clarity, confidence, and control.”

Founder, RIAR ConsultingAt RIAR Consulting, we work with manufacturers, distributors, and innovators to deliver regulatory clarity, reduce approval risks, and support sustainable commercialization strategies.

Why choose us

  • 01

    Global expertise, local execution

    Deep regulatory knowledge across SFDA, US FDA, CDSCO, EMA, and MHRA.

  • 02

    Structured and compliant approach

    Clear workflows, documentation discipline, and transparency at every stage.

  • 03

    Outcome-driven results

    We focus on regulatory approvals, minimize risks, and ensure efficient, compliant, and successful market entry globally.

Team

Our team

Founders, core team, senior consultants and advisors working across regulatory consulting and manufacturing intelligence.

  • Rishabh Dubey

    Founder and CEO

  • Shivam Kumar

    Co-Founder and CTO

  • Dr. Amitabh Tripathi

    Co-Founder and COO

How we work

From first call to a filed submission

Three steps. At every point you know what happens next and who is doing it.

  1. 01

    Exploratory call

    We go through your product, target markets and timeline, and tell you plainly what the approval route looks like.

    Step 1, week 1

  2. 02

    Gap review

    You share your documentation. We check it against what the authority expects and send a written assessment.

    Step 2, weeks 1 to 3

  3. 03

    Plan and execution

    A defined plan, a named lead, and hands-on support through submission, queries and the decision.

    Step 3, to approval

What every engagement is built on

  • Precise classification

    The right class and pathway from day one, so the file is built for the review it will actually get.

  • No shortcuts

    Every document rests on current regulation and guidance, not on what worked last time.

  • Measured on outcomes

    We judge our work by quality, compliance, execution and client outcomes, not by pages produced.

  • Visible progress

    Clear timelines, named owners and a running view of where the file stands.

  • Market-specific depth

    Working knowledge of how each of the five authorities reviews in practice.

  • One owner

    Each engagement is led by a senior regulatory professional, from first call to decision.

Clients

Clients who work with RIAR

Medical device manufacturers and distributors who have trusted RIAR with their regulatory work.

  • Medtronic
  • Abbott
  • Stryker
  • Arab East Medical

Our regulatory experience includes

  • SFDASaudi Arabia
  • US FDAUnited States
  • EMAEuropean Union
  • CDSCOIndia
  • MHRAUnited Kingdom

Tell us about your product or your plant

A 30-minute call about a regulatory route or a manufacturing intelligence requirement.

Book an exploratory call