MakroCare

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MakroCare is Expert Strategic development and commercialization global partner for pharmaceutical, biotechnology and medical device industries.

Established in 1996 with USA (NJ) as HQ, MakroCare is an innovative provider of strategic solutions that deliver measurable value and setting the highest standards of service to advance the global success of our clients. MakroCare strives to be the most reliable and premier partner that inspires valuable and ensuring solutions to the Life Sciences industry. MakroCare has 5 focus areas that include:

1) Strategy & Consulting
2) Regulatory Affairs (product life cycle, submissions)
3) Development (CPC, PACE, Trial Management, Biometrics)
4) Medical (risk management/safety & medical affairs)
5) Technology (products & solutions)

The executive management team of MakroCare comprises individuals who have a proven track record with regard to providing services to Pharmaceutical, Biotechnology, Device and Consumer Health industries. MakroCare has headquarters in New Jersey (USA) and has offices located in USA, UK, Europe, India, Singapore, China and Japan.

10/27/2026

Strengthen Your Medical Device Clinical Evaluation with MakroCare

A well-prepared Clinical Evaluation Report (CER) helps demonstrate the safety and performance of medical devices.

MakroCare supports manufacturers with:
🔍 CER gap analysis and updates
📚 Scientific literature searches and evidence appraisal
📊 Clinical data and benefit-risk assessment
📝 CER preparation and documentation
✅ Support aligned with applicable regulatory guidelines

Explore MakroCare’s CER services:
🔗 https://www.makrocare.com/devices/clinical/clinical-evaluation-reports/

10/06/2026

Need to strengthen your PMCF program?
From planning the right approach to analyzing data and preparing reports, MakroCare supports medical device companies across the PMCF lifecycle.

📋 PMCF strategy and planning
🧪 Study design and conduct
📊 Data analysis
📝 Interim and final PMCF reports
🔍 Monitoring and clinical data evaluation

Learn more:
🔗 https://www.makrocare.com/devices/clinical/pmcf/

09/29/2026

🚀 Make Nonclinical Data Submission More Efficient with MakroCare

Turn complex nonclinical study data into standardized, regulatory-ready SEND datasets with expert support.

✨ CDISC SEND implementation
📊 Data collection and transformation
🔄 SEND-compliant data mapping
🔍 Rigorous validation and quality review
📋 Support for multiple nonclinical study types
🎯 Submission-ready data for regulatory authorities

Discover MakroCare's CDISC SEND services:
https://www.makrocare.com/biopharma/cdisc-non-clinical-send/

09/22/2026

🧪 Medical Device Usability Testing with MakroCare

Medical devices must be safe and effective for their intended users. MakroCare provides full life-cycle usability testing support aligned with regulatory and standards requirements.

👥 Target user and task identification
🔍 Heuristic evaluation and risk review
🧪 Formative usability testing
📋 Human factors validation testing
📊 Analysis and formal reporting
✅ Support for FDA 510(k) and EU MDR CE submissions

Learn more:
https://www.makrocare.com/devices/technical/medical-device-usability-testing/

09/15/2026

📄 Global Regulatory Publishing & eCTD Submission Support
Regulatory publishing requires accuracy, consistency, and strong quality control. MakroCare supports biopharma companies with global regulatory publishing and submission services.

📑 Document, report, and submission publishing
🌍 eCTD, NeeS, and country-specific publishing
🔍 Technical QC, validation, bookmarking, and hyperlinking
📋 Support for IND, NDA, MAA, ANDA, DMF, amendments, and supplements
⚡ Efficient, submission-ready workflows

Learn more:
https://www.makrocare.com/biopharma/regulatory/publishing/

08/24/2026

🧪 Build Safer, More Usable Medical Devices with MakroCare

Usability testing helps medical device manufacturers evaluate how effectively and safely users interact with their devices.

MakroCare supports:
👥 User interaction and usability evaluation
🔍 Identification of potential use-related risks
📋 Usability testing planning and documentation
📊 Analysis of user feedback and test outcomes
✅ Support for regulatory and safety requirements

Learn more:
https://www.makrocare.com/devices/technical/medical-device-usability-testing/

08/18/2026

🧬 Simplify Non-clinical Data Submission with CDISC SEND

MakroCare helps life sciences organizations manage non-clinical study data using CDISC SEND standards, supporting efficient and consistent regulatory submissions.

📊 CDISC SEND implementation support
🔄 Nonclinical data transformation and standardization
🔍 Data validation and quality checks
📋 Submission-ready SEND datasets
🌍 Regulatory submission support

Learn more:
https://www.makrocare.com/biopharma/cdisc-non-clinical-send/

08/11/2026

📋 Strengthen Your Medical Device Clinical Evaluation

A robust Clinical Evaluation Report is essential for demonstrating the safety, performance, and clinical benefits of medical devices.

MakroCare supports manufacturers with:
🔍 Clinical evidence assessment
📚 Literature review and analysis
📊 Clinical data evaluation
📝 CER preparation and documentation
✅ Regulatory-focused clinical evaluation support

Learn more:
https://www.makrocare.com/devices/clinical/clinical-evaluation-reports/

08/06/2026

🚀 Accelerate Your Global Regulatory Submissions with MakroCare

From submission planning to final publishing, MakroCare helps ensure every submission is accurate, compliant, and delivered on time.

✨ eCTD and non-eCTD expertise
📋 End-to-end submission lifecycle support
🔍 Technical validation and quality checks
🌍 Global regulatory compliance
⚡ Reliable delivery across worldwide markets

Discover more:
https://www.makrocare.com/biopharma/regulatory/submission-management/

Address

116 Village Boulevard, Suite 200
South Brunswick Township, NJ
08540

Telephone

+18889310060

Website

http://www.makrocare.com/

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