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.

12/24/2025

🎄✨ Merry Christmas from MakroCare! ✨🎄

As we celebrate this festive season, we’re grateful for our amazing partners and teams who help advance safe, compliant, and innovative healthcare solutions every day.

May your holidays be filled with joy, good health, and new opportunities in the year ahead 🎁🌟

12/17/2025

Season’s Greetings from MakroCare! ✨🎄

Thank you to our amazing clients, partners, and team members for being part of our journey this year. Your trust and support inspire us every day.

Wishing you joy, peace, and success this holiday season and in the year ahead! 🎁❄️

12/16/2025

High-quality medical writing is essential for compliant, submission-ready documentation.
MakroCare supports Biotech, Pharma, Consumer Health & Medical Device companies with:

📝 Regulatory & clinical documentation
📊 CSR, Protocols, IBs, SAPs, CER/PER, PMS plans
🔍 Scientific accuracy & evidence alignment
🛡️ Compliance with FDA, EMA, ICH & global guidelines
🤝 End-to-end writing, QC, and publishing support

Strengthen your regulatory strategy with precise, audit-ready documents.
🔗 https://www.makrocare.com/biopharma/clinical/medical-writing/

12/09/2025

Ensure safer, user-friendly medical devices - backed by rigorous usability testing.

At MakroCare, we help device manufacturers meet FDA, MDR, IEC 62366 requirements through:
🧪 Human factors validation
👥 User experience evaluation
📊 Simulated-use studies & risk control
🎯 Clinical workflow fit & usability documentation

🛡️ Reduce use errors, accelerate approvals, and launch confidently with MakroCare.
🔗 Explore more: https://www.makrocare.com/devices/technical/medical-device-usability-testing/

12/02/2025

Need seamless, compliant regulatory submissions across geographies? At MakroCare, our experts manage eCTD-based filings and lifecycle submissions - covering clinical applications, market authorizations, amendments and life-cycle management - across 100+ countries 🌍.

✨ We ensure:
📄 Full compliance with global authority standards (FDA, EMA & beyond)
⏱️ Structured documentation, error-free submissions and fast turnaround
🌐 End-to-end submission management: from publishing to submission tracking, worldwide

Partner with experts - get your regulatory pathway right the first time.
📌 Explore more: https://www.makrocare.com/biopharma/regulatory/operations/sub-management/

11/27/2025

Happy Thanksgiving from Team DDi! 🦃🍁

Today, we’re thankful for our amazing clients, partners, and global teams who inspire us every day.
Your support motivates us to build smarter, AI-driven solutions that make life sciences better, faster, and more connected.

May your Thanksgiving be filled with warmth, joy, and togetherness! 🧡🍽️

Happy Thanksgiving!

11/25/2025

Bringing a medical device to global markets demands precision, compliance, and speed.
MakroCare’s Medical Device Registrations & Dossiers services help manufacturers navigate complex regulatory pathways with confidence.

✨ What we offer:
🔹 End-to-end global device registrations
🔹 Country-specific dossier preparation (EU, US, APAC, LATAM & more)
🔹 Gap analysis & remediation
🔹 RA strategy, submission management & lifecycle support

With expert regulatory teams and decades of experience, MakroCare ensures your submissions are accurate, audit-ready, and future-proof.
📌 Explore more: makrocare.com/devices/regulatory/registrations-dossiers/

11/11/2025

Ensuring CMC compliance across global markets is a challenge many BioPharma organizations face.
MakroCare supports companies end-to-end with CMC Regulatory Consulting Services from product development to lifecycle management.

🔹 CMC Authoring (Module 2 & 3)
🔹 Regulatory Strategy & Gap Assessment
🔹 Change Control & Variations Management
🔹 Global Submission Support & Compliance Alignment

With deep regulatory expertise and a global delivery model, we help accelerate approvals and maintain compliance across regions.

Learn more: https://www.makrocare.com/biopharma/regulatory/authoring/cmc/

11/03/2025

Are you navigating the complex regulatory landscape of Software as a Medical Device (SaMD) or IVD-software? 🧬 At MakroCare, we partner with life-science organisations to deliver end-to-end regulatory, clinical and quality-services for SaMD/IVD products — from submission strategy through post-market lifecycle. 🚀

Our team brings:
✅ Deep expertise in global frameworks (US, EU, Asia) 🌍
✅ Technical and clinical compliance support (software lifecycle, validation, documentation) 📑
✅ Scalable solutions—whether full-service or functional modules to fit your needs 🔧

Leverage MakroCare’s proven track record to bring your software-driven medical innovation to market with confidence and speed.
🔗 Know More: https://www.makrocare.com/devices/software-as-medical-device-samd/

10/28/2025

Need audit-ready clinical documents that meet regulatory expectations — without delays?
Choose MakroCare Medical Writing Services.

Why Clients Trust Us:
💡 Deep scientific & regulatory expertise
🧠 Skilled writers across therapeutic areas
⏱️ Quality delivery with quick turnaround
📈 Supports faster approvals & submission success

Your data deserves to be communicated clearly.
🔗 Let’s get your documents submission-ready: https://www.makrocare.com/biopharma/clinical/medical-writing/

10/21/2025

🩺 Post-Market Clinical Follow-up (PMCF) is vital for ensuring your medical device continues to perform safely and effectively in real-world use.

✅ MakroCare helps manufacturers design, execute, and document robust PMCF plans aligned with MDR requirements.
📊 From data collection to clinical evaluation updates — our team ensures compliance and confidence in your device lifecycle.

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

10/13/2025

Ensuring nonclinical data integrity and global compliance starts with structured data standards.
At MakroCare, we support sponsors in implementing CDISC SEND, enabling smooth FDA submissions, enhanced traceability, and faster reviews.

✅ Standardized nonclinical datasets
✅ End-to-end SEND mapping & validation
✅ Global regulatory alignment

🔍 Let’s make your data submission seamless and compliant with CDISC SEND best practices.
Know more 👉 https://www.makrocare.com/biopharma/cdisc-non-clinical-send/

Address

4 Independence Way
South Brunswick Township, NJ
08540

Telephone

+18889310060

Website

http://www.makrocare.com/

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