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.

09/08/2025

🔍 Post-Market Clinical Follow-Up (PMCF) made simple

Your device is on the market ✅ but staying compliant & safe doesn’t stop there.

At MakroCare, we help you:
✨ Collect real-world clinical data
📑 Stay aligned with EU MDR & ISO 14155
🛡️ Strengthen safety & performance evidence

👉 Ensure your device continues to deliver safe outcomes throughout its lifecycle.

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

09/04/2025

✅ Regulatory submissions made easier!
Biopharma companies face increasing complexity in publishing submissions for global markets. Accuracy, compliance, and timeliness are critical - but they don’t have to be stressful.

💡 At MakroCare, our Regulatory Publishing Services help you:
✔ Prepare compliant eCTD and NeeS submissions
✔ Manage country-specific requirements
✔ Ensure error-free, on-time delivery
✔ Streamline global submission processes

🌍 Whether it’s IND, NDA, MAA, ANDA, or variations, our experts ensure your dossiers meet all regulatory expectations.

📌 Let us handle the complexity, so you focus on innovation.
👉 Learn more: https://www.makrocare.com/biopharma/regulatory/operations/publishing/

08/25/2025

🔍 Looking for seamless Medical Device Labeling & Artwork solutions? Meet MakroCare!

We offer:
✅ Label creation and artwork aligned with all regulatory needs
✅ Fully compliant packaging - from primary to secondary designs
✅ Support for UDI, eIFU, multilingual labels, and risk-safe materials
✅ Expert review across Medical, Regulatory, QA, and Artwork teams
✅ End-to-end process: strategy, mock-ups, translations, and compliance checks

Why choose MakroCare?
We ensure clarity, compliance, and patient safety - so your products get to the market faster and safer.

Reach out today to explore how we can support your labeling needs!
https://www.makrocare.com/devices/labeling/

08/18/2025

Launching SaMD? Don’t let compliance challenges hold you back. 90% of delays happen because of incomplete documentation.

MakroCare supports Software as a Medical Device (SaMD) & IVD developers with:
✅ Regulatory mastery – From submissions to lifecycle
✅ Technical excellence – ISO 62304, V&V, cybersecurity, usability
✅ Clinical strength – CER, CEP, PMS, risk-benefit analysis

Why struggle with compliance when you can partner with experts?
👉 Start your SaMD journey today: https://www.makrocare.com/devices/software-as-medical-device-samd/

08/11/2025

🖋️ Boost Your Clinical & Regulatory Impact with Clear, Compliant Writing

For over 20 years, MakroCare has supported Biotech, Pharma, Consumer Health, and Medical Device companies worldwide with high-quality medical writing services

Our expert team includes:
✅ Professionals with MBBS, MD, PhD, or Master’s degrees
✅ Deep familiarity with ICH-GCP, FDA & EMA guidelines

We help you create clear, concise, and accurate documents, including:
✅ Protocols, ICFs, Investigator’s Brochures
✅ Clinical Study Reports (CSRs), safety narratives
✅ Abstracts, manuscripts, regulatory submissions

Ready to elevate your documentation? Reach out to MakroCare’s skilled medical writers today!
🔗 Learn more: https://www.makrocare.com/biopharma/clinical/medical-writing/

08/04/2025

🧪 IVDR compliance isn’t optional - it’s essential.
But are you fully prepared to meet EU IVDR requirements?

🔍 MakroCare’s IVDR Gap Assessment Services help you identify what’s missing and what to fix - before it’s too late.

Here’s how we support you:
✅ Detailed gap analysis against IVDR requirements
✅ Roadmap to address technical & clinical gaps
✅ Support across QMS, PMS, PER & more
✅ Faster, smoother IVDR transition

📋 Whether you’re starting late or need a final check, we help you stay audit-ready and compliant.

🔗 Learn more: https://www.makrocare.com/devices/ivdr/

07/28/2025

🔬 Is your medical device truly user-friendly?
Even the most advanced technology can fall short if users find it difficult to operate. That’s where MakroCare’s Usability Testing services come in!

✅ Ensure device safety and effectiveness
✅ Meet FDA, MDR, and IEC 62366 compliance
✅ Identify design risks before it’s too late
✅ Improve user satisfaction & reduce errors

👩‍⚕️ Our experts work closely with real users - clinicians, patients, caregivers - to gather the insights you need to make smarter, safer design decisions.

📊 From formative to summative testing, we support you at every step of the product lifecycle.

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

07/21/2025

📊 Struggling with CDISC SEND compliance for your non-clinical studies?

MakroCare is here to help you streamline the entire SEND lifecycle — from data mapping to final submission. ✅

With our deep expertise in regulatory data standards and end-to-end SEND services, we ensure your data is:
🔹 Submission-ready
🔹 Aligned with FDA & global standards
🔹 Delivered with precision and compliance

Whether you're a sponsor or CRO, MakroCare can reduce your SEND workload and help you stay focused on science, not formatting.

📥 Explore our SEND solutions:
🔗 https://www.makrocare.com/biopharma/cdisc-non-clinical-send/

07/14/2025

🔍 Is your medical device truly safe in the real world?
It’s not just about getting to market - it’s about staying compliant after launch too.

That’s where Post-Market Surveillance (PMS) comes in. At MakroCare, we help MedTech companies monitor and manage the real-world performance of their devices - so you can detect issues early, stay compliant, and build trust. ✅

With our PMS services, you get:
📊 Systematic data collection & analysis
📄 Regulatory-compliant PMS plans & reports (EU MDR, FDA, etc.)
🔁 Proactive signal detection & trend analysis
🧠 Strategic inputs for product improvement & safety updates

🔗 Whether you're a startup or an established manufacturer, our experts support you every step of the way - from PMS planning to PSUR/PER writing.

Let’s make your device safer, smarter, and stronger in the market!
👉 Explore our PMS services: https://www.makrocare.com/devices/pms/post-market-surveillance/

07/07/2025

🔍 On the market? The real work starts now.
MakroCare supports full PMCF - from planning to reporting - so your device stays safe, compliant & MDR-ready.
👉 https://www.makrocare.com/devices/clinical/pmcf/

07/04/2025

🎆 Happy Independence Day, America!

Today, we celebrate the courage, freedom, and resilience that define this great nation. At MakroCare, we honor the spirit of innovation and perseverance that drives progress - both in life and in the life sciences.

Here's to liberty, opportunity, and a healthier tomorrow for all. Wishing our colleagues, clients, and partners in the U.S. a safe and joyful 4th of July! 🎇

06/30/2025

At MakroCare, we help you navigate complex global regulations with clarity and confidence. Whether you're at the concept stage or prepping for market entry, our experts guide you on:

✅ Global Regulatory Pathway Analysis
✅ Pre-submission Planning & Strategy
✅ Risk-based Device Classification
✅ Country-specific Regulatory Intelligence
✅ Gap Assessment & Remediation

💡 Smart strategy = faster approvals, fewer delays.

With experience across FDA, EU MDR, TGA, Health Canada & more 🌍 - MakroCare ensures your device is regulatory-ready at every step.

🔗 Learn how our tailored strategies can accelerate your product journey:
👉 https://www.makrocare.com/devices/regulatory/regulatory-strategy/

Address

4 Independence Way
South Brunswick Township, NJ
08540

Telephone

+18889310060

Website

http://www.makrocare.com/

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