RigorDx Solutions
IVD & medical device consultancy

From working prototype to licensed, repeatable production.

RigorDx Solutions takes Indian IVD manufacturers from a kit that works once to a production line that passes audits, lot after lot. Led by a principal consultant who has run reagent plants, not only written procedures for them.

Start a conversation See the services
  • Rapid (Lateral Flow)
  • ELISA
  • FIA
  • CLIA
Lot 7 should look like lot 1
+3 SD +2 SD Mean −2 SD −3 SD Lot 1234 5678 9101112 1314 Lots drift Validated, in control
Before and after a 3-lot process validation Illustrative lot-release chart, not client data.
25+
Years in IVD and life sciences operations
2
Reagent plants led, at Vizag and Daman
19
Specialist quality, regulatory and compliance services
Working across
  • ISO 13485:2016
  • ISO 14971
  • CAPA
  • CDSCO
  • FDA 510(k)/PMA
  • EU MDR/IVDR
  • MDSAP
  • WHO PQ
The problem

Most kits work once. Making lot 7 match lot 1 is the hard part.

Most IVD companies can make a kit that works once. They struggle to make lot 7 behave like lot 1, to pass a CDSCO or MDSAP audit, and to document the plant and the product in a form regulators accept.

Generalist consultants write procedures. Few have run a reagents plant. RigorDx has, and every engagement is built around that difference.

Who we work with
  • First-time and early-stage IVD manufacturersRapid tests, ELISA, FIA and CLIA makers with a working prototype and no licence yet.
  • Mid-size licenseesFirms failing audits or struggling with lot-to-lot consistency.
  • Overseas companies localizing in IndiaManufacturers moving production and regulatory presence into the Indian market.
Services

Three practice areas, one principal consultant.

  • IVD Product Development

    Rapid, ELISA, FIA and CLIA, from assay concept to a manufacturing-ready technology package.

  • Manufacturing Scale-Up

    Process validation, tech transfer and plant planning that protect quality, yield and margin.

  • Quality, Regulatory & Compliance

    19 specialist services across ISO 13485, ISO 14971, CAPA, CDSCO, FDA and EU MDR/IVDR.

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Ready to talk about your product or plant?

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Services

Three services, each with a framework and a clear outcome.

Engage one, or follow the whole path. Each service follows a four-step framework and ends in documents and systems your own team can run.

Service 1 of 3

IVD Product Development

Rapid (Lateral Flow), ELISA, FIA and CLIA, from assay concept to a manufacturing-ready technology package.

  • Assay and reagent design across Rapid, ELISA, FIA and CLIA platforms, with formulation and feasibility guidance grounded in hands-on reagent development
  • Technology transfer from R&D to manufacturing that preserves analytical performance and reproducibility at scale
  • Analytical and clinical performance evaluation support for launch and regulatory submission
  • Design controls, stability, and verification and validation planning
  • Design History File architecture that stays audit-ready from day one, not retrofitted later
Key deliverables
  • Feasibility and formulation report
  • Platform-specific technology transfer package
  • Analytical / clinical evaluation protocol
  • Design History File (DHF) setup
Value to you

A product designed to be manufactured and filed. Assay performance, documentation and the technology package are ready for transfer, so you do not rework the design at scale or at submission.

Our framework: Define, Design, Verify, Hand over
  1. DefineIntended use, platform and performance targets
  2. DesignFormulation, feasibility and design controls
  3. VerifyEvaluation protocols and stability
  4. Hand overDHF and a technology package ready for transfer
Service 2 of 3

Manufacturing Scale-Up

Scaling reagent and device production without losing quality, yield or margin.

  • Facility and production-line planning: layout, utilities, equipment, workflow, cleanroom and cold-chain
  • Process validation and technology transfer, from lab bench to commercial scale with repeatable outcomes
  • Raw material qualification, lot-release targets and cost per reportable result
  • Lean Six Sigma optimization of yield, cost and cycle time, using Green Belt methodology
  • Supply chain and procurement strategy: vendor qualification and sourcing that protect continuity and cost
Key deliverables
  • Scale-up and tech transfer plan
  • Process validation protocols (IQ/OQ/PQ)
  • Yield and cost optimization report
  • Vendor qualification framework
Value to you

Lot 7 behaves like lot 1. Validated processes, qualified raw materials and a known cost per reportable result let you scale volume without losing yield or margin.

Our framework: Assess, Validate, Transfer, Stabilise
  1. AssessPlant, process, raw materials, yield and cost per reportable result
  2. ValidateIQ/OQ/PQ, 3-lot validation, lot-release and CV% targets
  3. TransferMove to the commercial line and qualify vendors
  4. StabiliseLean Six Sigma improvement and team coaching until lots hold
Service 3 of 3

Quality, Regulatory & Compliance

19 specialist services spanning ISO 13485, ISO 14971, CAPA, and technical submissions for CDSCO, FDA and EU MDR/IVDR.

  • QMS establishment and remediation to ISO 13485:2016, including gap assessment and non-conformance closure
  • ISO 14971 risk management and CAPA systems built on defensible root-cause analysis and effectiveness verification
  • Regulatory strategy and technical file or design dossier compilation for CDSCO, FDA 510(k)/PMA and EU MDR/IVDR, including PMF/DMF and licensing
  • Mock audits, and MDSAP, IVDR and WHO PQ gap assessments
  • Internal and supplier audits, document control, and post-market surveillance, including complaints, recalls and PSUR reporting
Key deliverables
  • Quality manual and SOP suite
  • Risk Management File (FMEA) and CAPA system
  • Regulatory strategy roadmap and technical file
  • Post-Market Surveillance plan and PSUR
Value to you

A licensed, audit-ready operation. A quality system and technical files that regulators accept, and a team that can run them after we leave.

Our framework: Assess, Build, Prove, Sustain
  1. AssessGap audit against ISO 13485 and MDR 2017, with a 90-day plan
  2. BuildQMS, risk files, CAPA and technical file or PMF/DMF
  3. ProveMock audit and MDSAP, IVDR and WHO PQ gap assessments
  4. SustainInternal audits, post-market surveillance and ongoing support
See all 19 quality, regulatory and compliance services

Quality & Compliance Systems (11)

  1. QMS Consultancy, Remediation & Establishment
  2. ISO 14971 Risk Management
  3. CAPA Management
  4. Compliance, Audit & Validation
  5. Document Management
  6. Supplier Evaluation
  7. Post-Market Surveillance
  8. Product Complaints Management
  9. Device Recall, Corrections & Removals
  10. Health Hazard Evaluation (HHE)
  11. Medical Device Translation Services

Medical Devices & Regulatory Affairs (8)

  1. Regulatory Affairs and Consulting
  2. Device Documentation & Technical Writing
  3. Biocompatibility Services
  4. Human Factors Engineering
  5. Labelling and Regulatory Artwork Services
  6. Medical & Scientific Communication
  7. Regulatory Staff Augmentation
  8. M&A Regulatory Services
How we work

Start small with an assessment, then build.

Engagements are fixed-scope with milestone billing and clear deliverables. Every project ends with a working system your own team can run.

  1. STEP 1

    Readiness Assessment

    Gap audit against ISO 13485 and MDR 2017, a plant walk-through, a scored report and a 90-day action plan.

    Best for: anyone unsure where they stand, or facing a CDSCO or MDSAP auditTimeline: 2 to 3 weeks
  2. STEP 2

    Compliance Build

    QMS set-up or upgrade, PMF/DMF preparation, licensing support, a CAPA system and a mock audit.

    Best for: first-time licensees and firms with audit findingsTimeline: 3 to 6 months
  3. STEP 3

    Scale-Up and Tech Transfer

    Process validation, raw material qualification, lot-release and CV% targets, and a cost per reportable result review.

    Best for: startups with a working prototype, or firms with failed lotsTimeline: 4 to 9 months
  4. STEP 4

    Fractional Operations Retainer

    Two to three days a month of senior advice on audit readiness, supplier issues, team coaching and management reviews.

    Best for: clients finishing steps 2 or 3 who want continuityTerm: 6-month minimum
Plant set-up and product developmentLayout, utilities, cleanroom and cold-chain planning, or design controls, stability and V&V plans, are quoted per project after the assessment.
Interim leadership and trainingFractional or interim Operations, Quality or Regulatory Head cover during a transition, and workshops for your team on GMP, Six Sigma and regulatory fundamentals.

Start with a readiness assessment.

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Why RigorDx

Why IVD manufacturers choose a practitioner over a generalist.

Many consultancies can write a procedure. Few have run a reagents plant, passed the audit and fixed the lot that failed. That experience is what we sell.

How RigorDx differs from a typical generalist consultancy
 Typical generalist consultancyRigorDx Solutions
BackgroundDocumentation and regulatory writing across many device types25+ years running IVD and reagent operations, including two plants
Starting pointProcedures and templatesA scored readiness assessment of your plant and product, with a 90-day plan
ScopeOne function, such as a filing or a QMSProduct development, scale-up, and quality and regulatory under one principal consultant
Lot consistencyUsually outside the briefProcess validation, raw material qualification and lot-release targets are core work
Regulatory viewOften a single marketISO 13485, MDR, IVDR, WHO, QSR, CDSCO and FDA
Commercial modelOpen-ended time and materialsFixed scope, milestone billing and defined deliverables
At handoverDocuments deliveredA working system your own team can run

The comparison describes typical generalist practice. Individual firms vary.

What sets us apart

Five commitments behind every engagement.

  • We have run the plant

    Our founder has led reagent manufacturing across two facilities. You get advice from someone who has faced the audit and the failed lot, not only the standard.

  • One partner from concept to submission

    Product development, manufacturing scale-up, and quality and regulatory work sit under one roof, so nothing is lost between stages.

  • Global regulatory fluency

    Working knowledge of ISO 13485, MDR, IVDR, WHO and QSR frameworks, plus CDSCO and FDA pathways, rather than a single-market view.

  • Systems sized for you

    Lean Six Sigma thinking keeps systems practical: built to pass audits and run day to day, and not over-engineered for your size.

  • Fixed scope, clear deliverables

    Milestone-billed engagements with agreed deliverables, and a handover that leaves your team able to run what we built.

What we do not promise

We advise. We do not guarantee a licence or an audit result, because those decisions belong to the regulator. We do promise a clear reading of where you stand, and a plan built on evidence.

Other routes

The other ways IVD companies get help, and where each stops short.

Each of these routes has a real place. RigorDx fills the gap they leave: the plant floor and the lot-to-lot result.

  • Regulatory and licensing firms

    Strong on filings, registrations and licence paperwork. Process validation, raw material qualification and lot-release work usually sit outside the brief. RigorDx adds the manufacturing side, so the licence and the production line match.

  • Kit makers who also consult

    Useful assay knowledge, but their advice can be tied to their own products and capacity. RigorDx is independent: advice is the only thing we sell, and your technology stays yours.

  • OEM and contract manufacturing

    A quick route to market, but you depend on someone else’s plant and build no capability of your own. RigorDx helps you build your own line, quality system and team.

  • Large global regulatory firms

    Typically built for registrations across many markets. RigorDx works alongside your team on the Indian plant floor, then on the submission.

Descriptions are general and drawn from public information. Individual firms vary.

See where your plant and product stand.

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About us

Built by someone who spent 25 years making diagnostics work at scale.

RigorDx Solutions is the advisory Atul Chandra Jha wanted to see when he was the one running the plant: practitioner-led, end-to-end, and accountable for results that hold from lot to lot.

  1. 2002At the bench

    Learning that a result is only worth what you can repeat

    Atul began as a Research Associate at J Mitra & Co, after an M.Sc. in Biotechnology from G.G. University, Bilaspur. Working with reagents and assays every day taught him the lesson that still shapes RigorDx: a result matters only if it can be repeated.

  2. 2006 to 2017Discipline at scale

    Eleven years inside a global life sciences company

    At Merck Life Science he earned his Six Sigma Lean Green Belt and saw what disciplined, documented, repeatable work looks like when it is the standard rather than the exception.

  3. 2018 to 2026Running IVD operations

    From quality operations to leading two reagent plants

    He moved into IVD leadership: quality operations at Bhat Biotech, the IVD division at Promea Therapeutics, operations at MP Biomedical India, and then reagent manufacturing across the Vizag and Daman plants at Transasia Diagnostics. Along the way he went through the audits, the technology transfers and the lots that did not behave.

  4. TodayBuilding RigorDx

    The advisory firm the industry kept missing

    The same pattern kept appearing. Companies could make a kit that worked once. Making lot 7 match lot 1, passing a CDSCO or MDSAP audit and documenting the plant in a form regulators accept was where they struggled, and the help on offer often came from people who had written procedures but never run a reagents plant.

    RigorDx exists to close that gap. It takes a working prototype to a licensed, repeatable production line, and leaves the client’s own team able to run it.

The name

Rigor is the discipline behind every reliable result. Dx is diagnostics. Together they state the promise: rigor in every lot.

Atul Chandra Jha, Founder and Principal Consultant of RigorDx Solutions
The founder

Led by a founder with 25 years of hands-on IVD operations.

RigorDx Solutions is led by Atul Chandra Jha, who has spent over 25 years in IVD and life sciences operations. He most recently led reagent manufacturing across the Vizag and Daman facilities at Transasia Diagnostics, and spent 11 years at Merck Life Science before that.

Clients get a practitioner who has scaled the lines and answered the auditors, with working knowledge of ISO 13485, MDR, IVDR, WHO and QSR frameworks.

  • M.Sc. Biotechnology
  • Six Sigma Lean Green Belt
  • GMP / GLP
  • ISO 13485:2016
  • EU MDR & IVDR
Atul Chandra Jha Founder & Principal Consultant
Career
  1. AGM, Reagents ManufacturingTransasia Diagnostics, Vizag and Daman
  2. Manager, OperationsMP Biomedical India
  3. Head, IVD DivisionPromea Therapeutics
  4. Senior Manager, Quality OperationsBhat Biotech
  5. Associate ScientistMerck Life Science
  6. Research AssociateJ Mitra & Co

Talk to the person who will do the work.

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Contact

Let’s talk about your product, your plant or your next audit.

Send a message and we will reply by email. You can also reach us directly using the details alongside.

Helpful to include: your assay platform, where you are today (prototype, pilot lots or licensed plant), and any audit or submission date.