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.

02/10/2026

A robust Quality Management System is the backbone of medical device compliance.
MakroCare supports manufacturers with expert QMS consulting and SOP management aligned to global standards.

📘 QMS design and gap assessment
🗂️ SOP creation, review, and harmonization
🌍 Alignment with ISO 13485, FDA QSR, EU MDR
🔍 Audit readiness and inspection support
⚙️ Process standardization across teams

Build a compliant, inspection ready QMS with confidence.
Learn more: https://www.makrocare.com/devices/qa-qms/

01/21/2026

A strong regulatory strategy is the foundation of successful medical device approvals.
MakroCare helps manufacturers define the right regulatory pathway and ex*****on plan across global markets.

🧭 Regulatory pathway assessment and planning
📋 Device classification and intended use alignment
🌍 FDA, EU MDR, UKCA and global strategy
📊 Gap analysis and evidence planning
🛡️ Risk-based, approval focused approach

Build a clear, defensible strategy before you submit.
👉 https://www.makrocare.com/devices/regulatory/regulatory-strategy/

01/12/2026

Robust CMC strategy and documentation are critical to successful global submissions.
MakroCare delivers end-to-end CMC regulatory consulting across development stages and markets.

🧪 Drug substance & drug product CMC authoring
📁 Module 2 & 3 (CTD/eCTD) expertise
🌍 FDA, EMA, MHRA & global compliance
🔍 Gap assessments & lifecycle management
🛡️ Submission-ready, audit-compliant dossiers

Enable predictable approvals with expert-led CMC ex*****on.
👉 https://www.makrocare.com/biopharma/regulatory/authoring/cmc/

01/06/2026

Global medical device registrations require precision, strategy, and regulatory clarity.
MakroCare supports manufacturers with end-to-end registration & dossier services across global markets.

📁 Country-specific registration dossiers
🌍 FDA, EU MDR/IVDR, UKCA, APAC & RoW markets
📊 Technical documentation & gap assessments
🔍 Classification, pathway & evidence alignment
🛡️ Submission-ready, audit-compliant dossiers

Accelerate approvals with expert-led regulatory ex*****on.
🔗 Explore more: https://www.makrocare.com/devices/regulatory/registrations-dossiers/

12/31/2025

Happy New Year 2026! 🎊

As we welcome a brand-new year, MakroCare looks forward to continuing our journey of supporting life sciences organizations with reliable regulatory, clinical, and compliance solutions.

✨ New goals
✨ Stronger collaborations
✨ Better outcomes for patients worldwide

Wishing everyone a year filled with success, health, and innovation! 💙

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!

Address

4 Independence Way
South Brunswick Township, NJ
08540

Telephone

+18889310060

Website

http://www.makrocare.com/

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