MakroCare

MakroCare 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.

🧪 Build Safer, More Usable Medical Devices with MakroCareUsability testing helps medical device manufacturers evaluate h...
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/

🧬 Simplify Non-clinical Data Submission with CDISC SENDMakroCare helps life sciences organizations manage non-clinical s...
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/

📋 Strengthen Your Medical Device Clinical EvaluationA robust Clinical Evaluation Report is essential for demonstrating t...
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/

🚀 Accelerate Your Global Regulatory Submissions with MakroCareFrom submission planning to final publishing, MakroCare he...
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/

📈 Strengthen Your Post-Market Clinical Evidence with ConfidencePost Market Clinical Follow-up (PMCF) is essential for de...
07/30/2026

📈 Strengthen Your Post-Market Clinical Evidence with Confidence

Post Market Clinical Follow-up (PMCF) is essential for demonstrating the ongoing safety and performance of medical devices. MakroCare helps manufacturers stay compliant with expert PMCF consulting.

✅ PMCF strategy and planning
📋 PMCF Plan and Evaluation Report support
🔍 Clinical data collection and analysis
🌍 MDR-compliant documentation
⚡ Timely, audit-ready deliverables

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

📄 Global Regulatory Publishing. Delivered Right the First Time.Regulatory submissions require precision, speed, and comp...
07/20/2026

📄 Global Regulatory Publishing. Delivered Right the First Time.

Regulatory submissions require precision, speed, and compliance. MakroCare helps biopharma companies streamline global publishing with expert support.

✅ eCTD & non-eCTD publishing
📑 Submission compilation & lifecycle management
🔍 Quality review & technical validation
🌍 FDA, EMA & global health authority compliance
⚡ Faster, submission-ready deliverables

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

📋 Simplify your global medical device registrations with MakroCare.Our regulatory experts help manufacturers prepare acc...
07/16/2026

📋 Simplify your global medical device registrations with MakroCare.

Our regulatory experts help manufacturers prepare accurate, compliant, and submission-ready dossiers for global markets.

✅ Country-specific registration support
🌍 FDA, EU MDR/IVDR, UKCA & global market submissions
📑 Technical documentation and dossier preparation
🔍 Regulatory gap assessments and compliance guidance
⚡ Faster approvals through strategic regulatory support

Learn more:
https://www.makrocare.com/devices/regulatory/registrations-dossiers/

📊 Turn your non-clinical study data into regulatory-ready submissions with MakroCare's CDISC SEND services.Our experts h...
07/06/2026

📊 Turn your non-clinical study data into regulatory-ready submissions with MakroCare's CDISC SEND services.

Our experts help you with:
✅ CDISC SEND dataset conversion
✅ SENDIG-compliant data mapping
✅ Define.xml and metadata preparation
✅ Data quality validation
✅ Submission-ready deliverables for global regulatory agencies

Ensure accuracy, consistency, and compliance throughout your non-clinical data submission journey.
Learn more: https://www.makrocare.com/biopharma/cdisc-non-clinical-send/

🚀 Design medical devices with confidence through MakroCare's Usability Testing Services.Our experts help evaluate real-w...
06/29/2026

🚀 Design medical devices with confidence through MakroCare's Usability Testing Services.
Our experts help evaluate real-world user interactions, reduce use-related risks, and generate the evidence needed for successful regulatory submissions.

🎯 Human factors expertise
🎯 Comprehensive usability studies
🎯 Better user safety
🎯 Stronger regulatory readiness

Deliver devices that are built for both performance and safe use.

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

📑 Regulatory submissions demand accuracy, consistency, and adherence to evolving global health authority requirements.Ma...
06/22/2026

📑 Regulatory submissions demand accuracy, consistency, and adherence to evolving global health authority requirements.
MakroCare's Global Regulatory Publishing Services help organizations prepare, validate, and submit high-quality regulatory dossiers efficiently across multiple markets.

✅ eCTD publishing support
✅ Submission lifecycle management
✅ Quality review and validation
✅ Global regulatory expertise

Simplify complex publishing processes and stay submission-ready.

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

Address

4 Independence Way
South Brunswick Township, NJ
08540

Telephone

+18889310060

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