Morulaa
Morulaa is a Chennai, India-based regulatory consulting firm supporting 500+ medical device, IVD, and drug manufacturers with registration, technical documentation, quality management, and local representation across 30+ global markets.
- Company typePrivate
- Founded2012
- HeadquartersChennai, India
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Morulaa does
Morulaa HealthTech Pvt Ltd is a Chennai-headquartered regulatory consulting firm founded in 2012 that supports medical device, IVD, and drug manufacturers with global product registration, local representation, technical documentation, and quality management across 30+ markets. The firm serves 500+ manufacturers and has completed 999+ projects, with structured service pillars covering market access and registration, technical/clinical/regulatory documentation, and quality management and compliance (ISO 13485, FDA QMSR, MDSAP). Coverage spans India (CDSCO), EU (MDR/IVDR), USA (FDA 510(k), establishment registration), UK (MHRA, UKCA), Australia (TGA), ASEAN, LATAM, Africa, Central Asia/EAEU, Middle East, and APAC (China, Japan, South Korea).
Service delivery relies entirely on human expertise — a team of regulatory scientists, clinical evaluators, and quality engineers — with no proprietary software platform or AI/ML components described in source material. The firm operates as a professional services business under a sales-led and content-marketing GTM: outreach flows through website CTAs, a Knowledge Hub (articles, country guides, webinars) and a Downloads resource library, with a stated 24-hour response commitment to consultation requests and a single accountable project team per manufacturer spanning registration through post-market compliance. Pricing for the firm's own services is quote-based and not publicly disclosed; the publicly visible pricing data in source material references government-imposed regulatory fees (e.g., CDSCO, TGA, FDA 510(k), MHRA, ASEAN) rather than Morulaa's own commercial terms.
Morulaa is privately held and founder-owned. The leadership team comprises three women directors — Harshita Gupta (Managing Director and Co-founder), Vilina Jain (Director and Co-founder) and Kriti Gupta (Director) — and no external institutional investors, parent entities, or funding rounds were identified. Headquarters is in Chennai, India; all services are delivered directly by Morulaa and its local in-country partners without resellers or third-party distribution.
Morulaa firmographics
Firmographics- Name
- Morulaa
- Legal name
- Morulaa HealthTech Pvt Ltd
- Website
- https://morulaa.com
- Company type
- Private
- Founded year
- 2012
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Morulaa is a Chennai, India-based regulatory consulting firm supporting 500+ medical device, IVD, and drug manufacturers with registration, technical documentation, quality management, and local representation across 30+ global markets.
- Ownership category
- akta.pro rank
Morulaa industry classification
Industry- Product category
- Medical Device Regulatory Consulting
- NAICS
- Other Scientific and Technical Consulting Services (54169), Professional, Scientific, and Technical Services (541)
- SIC
- Services-Management Consulting Services (8742), Services-Management Services (8741)
- akta.pro primary industry
- Market Access, Pricing & Reimbursement (Evidence Generation) FSP (HLAGAOAN)
- akta.pro secondary industry
- Quality Assurance, GxP Compliance & Auditing FSP (HLAGAOAE)
Keywords
Where Morulaa is headquartered
LocationHeadquarters
- HQ city
- Chennai
- HQ country
- India
- HQ region
- Asia
Markets served
Morulaa business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Others
Revenue model
- Regulatory Consulting Services: Project-based and retainer consulting engagements covering medical device market access and registration, technical documentation preparation, clinical evaluation, quality management support, and post-market compliance across global markets. Services are structured around one coordinated project plan per manufacturer with a consistent point of contact.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Multi-year contract | CDSCO India registration fees by device class |
| Unit Pricing | Annual | TGA Australia ARTG inclusion fees by classification |
| One time/ perpetual license | Multi-year contract | FDA 510(k) submission user fees FY 2026 |
| Unit Pricing | Multi-year contract | MHRA UK medical device registration fee |
| Unit Pricing | Multi-year contract | ASEAN market registration fees vary by country and device class |
Go-to-market motion2 records
Distribution channels1 record
Marketing channels6 records
Morulaa product offering
Product offeringCore offering
Morulaa is a turnkey regulatory consulting firm that helps medical device and IVD manufacturers with product registration, local representation, technical documentation, quality systems, and market access across 30+ global markets. Services span three integrated pillars: (1) Medical Device Market Access & Registration covering classification, pathway planning, submission management, and authority-response support; (2) Technical, Clinical & Regulatory Documentation including technical files, clinical evaluation, risk management, and labelling; and (3) Quality Management & Compliance covering ISO 13485, FDA QMSR, and MDSAP, plus post-market compliance and vigilance.
Product overview
Morulaa is a global medical device regulatory consulting company that operates as a unified service platform rather than a software product. The core offering consists of three integrated service pillars: (1) Medical Device Market Access & Registration for regulatory pathway planning and submission management across 30+ global markets, (2) Technical, Clinical & Regulatory Documentation for technical files, clinical evaluation, risk management, and labeling, and (3) Quality Management & Compliance covering ISO 13485, FDA QMSR, and MDSAP. The company provides market-specific consulting services across India (CDSCO), EU (MDR/IVDR), Australia (TGA), USA (FDA), UK (MHRA), ASEAN, LATAM, Africa, Central Asia/EAEU, Middle East, and APAC regions, supported by a Knowledge Hub with regulatory articles, webinars, and downloadable resources.
Differentiator
Problem solved
Functional benefit
Products and services
- Medical Device Market Access & Registration
Quantifiable outcome
- Clients reportedly experience 80% fewer non-conformities compared to handling submissions alone when partnering with an experienced EU MDR consultant.
- +2 more outcomes
Companies that use Morulaa
Customer profileNamed customers1 record
Segments2 records
Ideal customer profiles1 record
Morulaa technology and API
TechnologyAPI detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Morulaa partnerships and signals
Strategic signalScale indicators5 records
Recent moves6 records
Expansion highlights5 records
Morulaa competitors and assessment
Company assessmentDirect peers
- Freyr Solutions: India-headquartered regulatory services provider specializing in medical device, IVD, and pharmaceutical registrations across global markets. Directly comparable in service mix, geographic breadth, and target customer profile to Morulaa.
- NAMSA: One of the largest dedicated medical device-focused CROs globally, offering regulatory, clinical, and quality consulting alongside laboratory testing. Closest scaled peer to Morulaa in pure medical device regulatory focus.
- RQM+: Medical device regulatory and quality consulting firm offering MDR/IVDR transition support, clinical evaluation, and post-market services. Competes head-to-head for the same mid-market medical device manufacturer wallet.
- I3CGLOBAL: India-based regulatory and clinical services firm serving medical device and pharmaceutical manufacturers with registration, documentation, and market access support. Similar geographic footprint and service delivery model.
- Elexes Medtech Consultancy: Boutique regulatory consultancy focused on medical device registrations across emerging and developed markets. Comparable service model and customer base to Morulaa, particularly for India and ASEAN-focused engagements.
Broad incumbents
- IQVIA: Global clinical research and life sciences services giant offering regulatory affairs, clinical operations, and quality consulting as part of a much broader portfolio. Represents the scaled end of competition Morulaa faces for enterprise medical device programs.
- ICON plc: Large global CRO with a regulatory services division serving medical device, biotech, and pharmaceutical sponsors. Competes with Morulaa for regulatory consulting work as part of broader integrated trial and submission programs.
- TÜV SÜD: Notified Body and global testing/certification organization that also offers pre-submission regulatory consulting for medical devices. Adjacent competitive threat, particularly in EU MDR/IVDR engagements.
- BSI Group: UK-based Notified Body and standards body providing ISO 13485 certification and increasingly regulatory consulting support. Comparable in the quality management and CE marking space that Morulaa serves.
Emerging players
- RegDesk (by ArisGlobal): Regulatory information management platform with a services overlay helping medical device and pharma companies track global registration requirements. Represents a tech-enabled adjacency to Morulaa's pure-services model.
Market position
Strengths4 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
Morulaa social profiles
Digital presenceMorulaa financial estimates
Financial estimateRevenue estimate
Valuation estimate
Morulaa leadership team
Management profileNumber of profiles
Profiles3 records
Morulaa funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Morulaa M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Morulaa
What does Morulaa do?
Morulaa is a turnkey regulatory consulting firm that helps medical device and IVD manufacturers with product registration, local representation, technical documentation, quality systems, and market access across 30+ global markets. Services span three integrated pillars: (1) Medical Device Market Access & Registration covering classification, pathway planning, submission management, and authority-response support; (2) Technical, Clinical & Regulatory Documentation including technical files, clinical evaluation, risk management, and labelling; and (3) Quality Management & Compliance covering ISO 13485, FDA QMSR, and MDSAP, plus post-market compliance and vigilance.
Is Morulaa a public or private company?
Morulaa is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Morulaa founded?
Morulaa was founded in 2012. It employs 11 to 50 people.
Where is Morulaa based?
Morulaa is headquartered in Chennai, India, in the Asia region.
How does Morulaa make money?
One revenue line is on record: regulatory Consulting Services.
Who are Morulaa's main competitors?
Direct peers on record are Freyr Solutions, NAMSA, RQM+, I3CGLOBAL and Elexes Medtech Consultancy. Broad incumbents are IQVIA, ICON plc, TÜV SÜD and BSI Group. RegDesk (by ArisGlobal) is listed as an emerging player.
Does Morulaa have an API?
No public API is recorded for Morulaa.
What industry is Morulaa in?
Morulaa's product category is Medical Device Regulatory Consulting. Its primary akta.pro industry code is HLAGAOAN, Market Access, Pricing & Reimbursement (Evidence Generation) FSP, with a secondary code of HLAGAOAE, Quality Assurance, GxP Compliance & Auditing FSP. Its NAICS code is 54169 and its SIC code is 8742.