MakroCare

What MakroCare does

MakroCare is a global regulatory affairs and clinical research consulting firm serving the biopharmaceutical and medical device industries. Founded circa 2002 and headquartered in Princeton, New Jersey, the company operates from nine offices spanning the United States (Princeton, San Francisco), the United Kingdom (London), Germany (Frankfurt), Poland (Warsaw), Singapore, China (Beijing), and India (Hyderabad, Mumbai), delivering services across 60+ countries to a base of 1,400+ customers supporting 4,000+ products. The service portfolio is structured around three integrated practice areas: regulatory affairs (strategy, registrations, publishing, CMC, labeling, lifecycle management), clinical research (CRO full service, central monitoring, biostatistics and SAS, medical writing, CDISC SEND/SDTM, late phase), and post-market/quality (PMCF, CER, IVDR, PMS, vigilance, QMS, risk management, usability testing, UDI, SaMD).

The platform is anchored by a proprietary clinical Total Quality Management (cTQM) quality framework, the REWOD electronic data capture system used for centralized monitoring, and standardized CDISC SEND/SDTM data structures for regulatory submissions. The firm is ISO 9001, ISO 13485, ISO 14155, and ISO 27001 certified, enabling it to serve as a quality and security-assured partner for enterprise clients. Engineering is delivered by 680+ full-time employees and consultants, including medical and scientific advisors with MD and PhD credentials in oncology, cardiology, psychiatry, and safety.

MakroCare generates revenue through professional services engagements — primarily project-based contracts and multi-year retainers — sold directly to enterprise pharmaceutical and medical device manufacturers via direct field sales, formal RFP/RFI processes, and inbound website inquiries. Customer logos span tier-one pharma (Pfizer, Roche, Merck, GSK, Johnson & Johnson, Bayer, Abbott, Nestlé) and major medical device companies (Stryker, BD, Intuitive, ConvaTec, Brainlab, Werfen), supplemented by a long tail of small and mid-cap biotech and device clients. The company is founder-led (President and Co-Founder Mahesh Malneedi), privately held with no disclosed institutional investors, and has earned multiple industry recognitions including three-time placement on the Inc. 5000 and Deloitte Technology FAST 500 lists.

Name

MakroCare

Legal name

MakroCare

Website

https://makrocare.com

Company type

Private

Founded year

2002

Operating status

Operating

Headcount range

501–1,000 employees

Short description

MakroCare is a global regulatory affairs and clinical research consulting firm serving biopharmaceutical and medical device companies. With 680+ consultants across nine offices and operations in 60+ countries, it delivers end-to-end regulatory strategy, clinical research, and post-market surveillance services to 1,400+ customers.

Ownership category

akta.pro rank

Product category

Regulatory and Clinical Consulting (CRO)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH), Risk Management & Benefit–Risk (RMP/REMS/PSUR-PBRER) (HLAGALAD), Clinical Trial Monitoring Support (On-site/Remote) (HLAGACAG)

Keywords

• Regulatory consulting services
• Clinical research organization
• Medical device compliance
• Pharmaceutical regulatory affairs
• Clinical trial management

Headquarters

HQ city

Princeton

HQ country

United States

HQ region

North America

Offices9 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Regulatory Consulting Services: MakroCare generates revenue through contract consulting engagements for regulatory strategy, submissions, publishing, labeling, CMC writing, and lifecycle management for biopharma and medical device companies. Services are delivered by 680+ FTEs and consultants across global offices. Engagements are project-based or retainer arrangements with pharmaceutical and medical device companies.
2. Clinical Research Services: CRO full-service clinical trial management including study management, central monitoring, late phase full service, biostatistics and SAS programming, medical writing, and clinical data management. Revenue generated through clinical trial project contracts with biopharma and device companies.
3. Medical/Scientific Writing Services: Scientific literature services, Clinical Evaluation Reports (CER), Performance Evaluation Reports (PER), Post-Market Clinical Follow-up (PMCF) reports, and technical documentation services. Billed as part of regulatory and clinical service engagements.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

MakroCare is a global Clinical Research Organization (CRO) and regulatory consulting firm delivering integrated regulatory affairs, clinical research, and post-market compliance services to biopharmaceutical and medical device companies. Its offering spans regulatory strategy and submissions, full-service clinical trial management, clinical data management and biostatistics, post-market clinical follow-up (PMCF), clinical and performance evaluation reports, IVDR compliance, QMS and risk management, usability testing, labeling and UDI consulting, and Software as a Medical Device (SaMD) advisory support across FDA, EU MDR/IVDR, and 60+ countries.

Product overview

MakroCare is a global Clinical Research Organization (CRO) and regulatory consulting firm offering a comprehensive suite of services for pharmaceutical, biotechnology, and medical device industries. The portfolio consists of integrated regulatory affairs services (Regulatory Strategy, Registrations & Dossiers, Publishing, CMC, Regulatory Intelligence), clinical research services (CRO Full Service, Clinical Data Management, Biostatistics & SAS, Central Monitoring, Medical Writing, CDISC SEND), and post-market compliance services (PMCF, CER/CEP, IVDR, PMS & Vigilance, QMS Management, Risk Management, Usability Testing, Labeling & UDI, SaMD). These services are delivered by a team of 680+ FTEs & Consultants across global offices, supporting 60+ countries, 4000+ products, and serving 1400+ customers. The company operates as a single integrated platform rather than modular products, providing end-to-end regulatory and clinical support from early development through post-market surveillance.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Strategy Services Strategic regulatory planning, market entry strategy, and risk management consulting for pharmaceutical, biotechnology, and medical device companies seeking to bring products to global markets.
• Regulatory Registrations & Dossiers Preparation and management of regulatory submissions and technical documentation for global market approvals across pharmaceutical and medical device product portfolios.
• CRO Full Service (Clinical Trial Management) End-to-end clinical trial management including trial management, clinical monitoring, site coordination, and central monitoring for medical device and biopharma studies.
• Clinical Data Management & Biostatistics Clinical data management, biostatistics, and SAS programming services for clinical trials, including CDISC SEND/SDTM standardization for regulatory submissions.
• Post-Market Clinical Follow-up (PMCF) Services EU MDR-compliant PMCF strategy, planning, conduct, data analysis, and reporting for medical devices, including prospective and retrospective study designs executed using the REWOD electronic data capture platform for centralized monitoring.
• Clinical Evaluation Reports (CER/CEP) Clinical Evaluation Report preparation for EU MDR compliance including benefit-risk determination and State of the Art benchmarking for medical devices.
• Performance Evaluation Reports (PER/PEP) Performance Evaluation Reports for in vitro diagnostic devices under IVDR compliance requirements.
• IVDR Consulting Services In Vitro Diagnostic Regulation (2017/746) compliance consulting including gap assessment, transition strategy, performance evaluation, CE marking support, and post-market performance follow-up for IVD manufacturers.
• QMS Management & Quality Assurance Quality Management System development, ISO 13485 certification support, and audit services to help medical device and pharmaceutical clients maintain regulatory compliance.
• Risk Management Services Risk management planning and documentation under ISO 14971 for medical devices, integrated into regulatory submissions and post-market activities.
• Medical Device Usability Testing Usability studies for medical devices that comply with US FDA, Brazil ANVISA, and EU MDR regulatory requirements, covering diverse user groups including healthcare professionals and patients.
• Post-Market Surveillance (PMS) & Vigilance Ongoing post-market surveillance, vigilance reporting, and adverse event management for medical devices to satisfy EU MDR and global post-market requirements.
• Labeling & UDI Consulting Global labeling strategy, Unique Device Identification (UDI) implementation, and electronic Instructions for Use (eIFU) services for medical device manufacturers.
• Biocompatibility & Biological Evaluation Report (BER) Services Biological evaluation planning and Biological Evaluation Report (BER) authoring to support medical device submissions.
• Software as a Medical Device (SaMD) Regulatory Services Regulatory strategy and clinical evaluation services for software-based medical devices, including SaMD classification, pathway planning, and submission support.
• Regulatory Publishing & Submission Management IND and NDA submission management, eCTD preparation, and regulatory publishing services for pharmaceutical clients.
• Medical Writing Services Clinical and non-clinical medical writing including protocols, clinical study reports, and regulatory documentation for pharmaceutical and medical device clients.
• Regulatory Intelligence Monitoring and analysis of global regulatory updates and policy changes affecting pharmaceutical and medical device product portfolios.
• CMC (Chemistry, Manufacturing and Controls) Writing Services CMC regulatory authoring and compliance support for pharmaceutical product development and submissions.
• Central Monitoring Services Risk-based central monitoring for clinical trials with remote data verification capabilities, supported by the REWOD electronic data capture platform.
• CDISC SEND Services Nonclinical data standardization using CDISC SEND format for FDA electronic submissions and global regulatory filings.

Quantifiable outcome

• Supports 60+ countries, 4,000+ products, and 1,400+ customers globally
• +1 more outcomes

Named customers24 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature5 records

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Medpace: Mid/large CRO focused on small and mid-sized biopharma with full-service clinical and regulatory capabilities. Operates in a similar mid-tier competitive segment to MakroCare with overlapping clinical research and regulatory service offerings.
• Premier Research: Mid-tier CRO with strong specialty therapeutics and medical device focus, offering clinical, regulatory, and consulting services. Comparable in scale, mid-market orientation, and regulatory + clinical integrated model to MakroCare.
• Parexel International: Global CRO with strong regulatory consulting and clinical trial services for biopharma and medical devices. Direct overlap with MakroCare on full-service regulatory strategy, clinical monitoring, biostatistics, and post-market services across multiple geographies.
• ICON plc: Large global CRO offering clinical research, biostatistics, regulatory affairs, and post-market services to pharma and medical device clients. Closely comparable to MakroCare on integrated regulatory + clinical model and enterprise pharma client base.
• Worldwide Clinical Trials: Mid-tier global CRO providing clinical trial management, biostatistics, regulatory, and post-market services to biopharma. Closely comparable mid-tier positioning, client mix, and service scope to MakroCare.
• Allucent: Mid-tier CRO with regulatory and clinical services for small/mid biopharma and medical device companies. Comparable mid-market positioning and integrated regulatory + clinical + post-market offering to MakroCare.

Regional players

• Frontage Laboratories: US-headquartered but China-rooted CRO providing bioanalytical, CMC, and clinical trial services to global biopharma. Comparable on integrated lab + clinical + regulatory service model, with a different geographic delivery mix.

Emerging players

• Inotiv: Contract research services company offering preclinical, clinical, and regulatory/medical device consulting. Comparable on the medical device regulatory and clinical evaluation services side that MakroCare provides.

Broad incumbents

• IQVIA: World's largest CRO with combined clinical, regulatory, real-world evidence, and technology offerings. Competes with MakroCare across virtually every service line but operates at vastly greater scale and with proprietary tech platforms.
• Charles River Laboratories: Diversified CRO offering preclinical, clinical, and manufacturing support to biopharma and medical device companies. Comparable on clinical and regulatory service overlap, broader in preclinical and CDMO verticals.

Market position

Strengths1 record

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/makrocare

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about MakroCare