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RIAR
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Noida, India ·

Regulatory expertise. Manufacturing intelligence.

RIAR Consulting supports pharmaceutical, biotechnology and other regulated life-sciences companies through regulatory consulting and manufacturing intelligence.

From regulatory strategy, dossier development and global market access to manufacturing visibility and early identification of operational risks, we help organisations make informed decisions across the product lifecycle.

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01 of 05Active

SFDA

Saudi Food and Drug Authority, Riyadh

Medicines
Drug registration (CTD/eCTD)
Devices
MDMA licence
  • CTD/eCTD dossiers
  • MDMA licensing
  • Query responses
key authorities
5
core capabilities
6
named lead per file
1
minute exploratory call
30
What we do

Two capabilities. One connected approach.

Your global regulatory and manufacturing intelligence partner.

  • 01

    Regulatory Consulting

    Navigate complex regulatory requirements through market-specific strategies, submission support, compliance and lifecycle management.

    Regulatory services

  • 02

    Manufacturing Intelligence

    Connect manufacturing signals, operational processes and critical plant conditions to identify emerging risks and support better-informed manufacturing decisions through VERA.

    Explore VERA 2.0

Continuous intelligence for pharmaceutical manufacturing

VERA 2.0 is RIAR’s Continuous Intelligence Manufacturing System. It connects manufacturing environments, interprets operational signals and supports earlier identification of potential risks. It is advisory only: it does not write to or control plant systems.

Explore VERA 2.0

Reach

Five authorities, one route map

I have a and want to sell in .

Regulatory pathway by product category

Indicative pathways only. Each product is assessed on its classification, target market and submission route; timelines are estimated per product and are not guaranteed approval periods.

  1. Active

    Saudi Food and Drug Authority, Riyadh

    Medicines
    Drug registration (CTD/eCTD)
    Devices
    MDMA licence

    What RIAR does

    • CTD/eCTD dossiers
    • MDMA licensing
    • Query responses
    Book a call about this route

  2. Active

    U.S. Food and Drug Administration, Silver Spring

    Medicines
    NDA, ANDA, BLA or IND
    Devices
    510(k) or De Novo

    What RIAR does

    • NDA and ANDA support
    • CMC documentation
    • 510(k) submissions
    Book a call about this route

  3. Active

    European Medicines Agency, Amsterdam, with EU notified bodies for devices

    Medicines
    Centralised, DCP, MRP or national
    Devices
    EU MDR, CE marking

    What RIAR does

    • CTD dossiers
    • Variations
    • Notified-body liaison
    Book a call about this route

  4. Active

    Central Drugs Standard Control Organisation, New Delhi

    Medicines
    New drug, import or manufacturing permission
    Devices
    Import or manufacturing licence

    What RIAR does

    • New drug and import support
    • Schedule M readiness
    • VERA 2.0 monitoring
    Book a call about this route

  5. Active

    Medicines and Healthcare products Regulatory Agency, London

    Medicines
    Marketing authorisation, national or recognition route
    Devices
    UKCA with UK Responsible Person

    What RIAR does

    • Marketing authorisations
    • Variations and renewals
    • UKCA technical files
    Book a call about this route

Global reach in detail

Pharma first

Where pharmaceutical science meets regulatory precision.

RIAR Consulting supports pharmaceutical, biotech, and life sciences companies with regulatory strategy, compliance, and manufacturing intelligence—helping businesses navigate complex requirements and make more informed decisions throughout the product lifecycle.

One file.

The core CTD content is written once, Module 1 for regional administrative requirements and Modules 2 to 5 for quality, non-clinical and clinical information, then adapted to each authority’s format, rules and reviewer expectations.

Built in pieces. Filed as one.

Most dossiers start like this: modules written by different teams, at different times, to different templates.

Modules aligned: 0 of 5

Services

Everything between your product and its approval

Six core regulatory capabilities, one team. Use them end to end, or bring us in at the point where you need support. Manufacturing intelligence is delivered separately through VERA 2.0.

  1. 01

    Regulatory strategy and consulting

    Global regulatory pathway assessment, product classification and regulatory positioning, gap analysis and market-entry planning, supported by country-specific regulatory intelligence.

    You get

    A regulatory pathway assessment and a submission plan for each target market.

    • Pathway
    • Classification
    • Gap analysis
    Scoped per product
  2. 02

    CTD/eCTD dossiers and technical files

    CTD and eCTD dossiers for medicines, and technical documentation for devices and IVDs, prepared, reviewed and compiled for each authority.

    You get

    A submission-ready dossier in the authority’s own structure, with gaps identified and remediated.

    • CTD
    • eCTD
    • Technical file
    Scoped per dossier
  3. 03

    CMC and pharmaceutical quality documentation

    Drug substance and drug product information, pharmaceutical development, manufacturing process, specifications, analytical methods and stability documentation.

    You get

    Quality and CMC documentation reviewed against the expectations of the target authority.

    • CMC
    • Specifications
    • Stability
    Scoped per dossier
  4. 04

    GMP and regulatory compliance

    GMP documentation review, quality system gap assessment, manufacturing site documentation and inspection-readiness support.

    You get

    A documented view of GMP and quality-system gaps, with support in responding to observations.

    • GMP
    • Inspection readiness
    • Quality systems
    Scoped per site
  5. 05

    Post-approval lifecycle management

    Variations and change management, renewals, product information updates and regulatory impact assessment, plus vigilance and post-market surveillance for devices.

    You get

    Lifecycle support that keeps authorisations and documentation current after approval.

    • Variations
    • Renewals
    • Vigilance
    Ongoing
  6. 06

    Regulatory queries and authority communication

    Assessment of authority queries and deficiencies, preparation of technical responses and coordination of regulatory correspondence.

    You get

    Coordinated, documented responses to authority questions and deficiency observations.

    • Queries
    • Deficiencies
    • Correspondence
    As queries arise

All services   Manufacturing intelligence

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
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.

I have a pharmaceutical product and want to register it in Saudi Arabia.

Exploratory call

Step 1, week 1

Exploratory call

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

  • Likely route
  • Main risks
  • Realistic timeline
Gap review

Step 2, weeks 1 to 3

Gap review

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

  1. 1CTD dossier
  2. 2CMC data
  3. 3Labelling
Plan and execution

Step 3, to approval

Plan and execution

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

Filed submission

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.

About RIAR

FAQ

Questions we are asked first

Do we need a local representative to register in Saudi Arabia?

Yes. A manufacturer outside Saudi Arabia needs an Authorised Representative in the Kingdom to hold the registration with SFDA. RIAR acts as that representative and manages the licence on your behalf.

Can one dossier serve several authorities?

The evidence can. The structure cannot. We write the core content once, then adapt it to each authority’s format, rules and reviewer expectations, so a second market builds on the first instead of starting over.

What happens on the exploratory call?

Thirty minutes with a regulatory lead. You describe the product and the markets; we tell you the likely route, the main risks and a realistic timeline. There is no obligation and no fee.

Does VERA directly control manufacturing equipment?

No. VERA is designed as an advisory intelligence system. It does not directly write to or control plant systems, and operational decisions remain with authorised personnel.

Do you work with distributors as well as manufacturers?

Yes. Distributors bringing products into a market need the same licences and the same documentation. We handle both sides and keep the manufacturer and the distributor on one plan.

All questions

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

Meet the team

Insights

Insights from RIAR Consulting

Regulatory developments, pharmaceutical manufacturing and industry intelligence: technical analysis of the changes shaping regulated markets and manufacturing operations.

  • 11 Sep 2026

    From manufacturing problems to medicine shortages

    How manufacturing problems can turn into medicine shortages, and what that means for regulated manufacturers.

    Read the note

  • 13 Jun 2026

    Printing ink for tobacco and cigarette packaging

    Performance and compliance requirements for regulated packaging inks.

    Read the note

  • 2 Feb 2026

    India–EU trade deal: what it means for Indian pharma in Europe

    Where the market opens, what stays hard, and where Indian manufacturers should start.

    Read the note

All articles

Contact

Tell us about your product or your plant

A 30-minute call about a regulatory route or a manufacturing intelligence requirement. For regulatory enquiries, you leave with the likely route, the main risks and a realistic timeline.

Required fields

We store the details you send so we can reply to your request. They are never shared or published.

We reply within one business day.

Our officePlatina Heights, Sector 62Noida, Uttar Pradesh, India Get directions