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.

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/

10/06/2025

Are you confident your device meets global regulatory expectations? 🌍
At MakroCare, we design clear, compliant Regulatory Strategies to help you navigate FDA, EU MDR, and other market pathways with precision.

Our experts help you:
✅ Identify the right submission route
✅ Optimize documentation
✅ Manage lifecycle changes efficiently

📈 Simplify compliance. Accelerate approvals.
🔗 Learn more: https://www.makrocare.com/devices/regulatory/regulatory-strategy/

09/23/2025

✨ Streamline Your Regulatory Publishing with MakroCare ✨
Regulatory publishing can be 🕒 time-consuming, repetitive, and stressful - especially with last-minute changes. That’s where MakroCare steps in.

Here’s how we make it easier:
✅ Over 20 years of experience with 500+ customers served globally.
✅ 24×7 operations, submitting to FDA, EMA and other authorities all over the world.
✅ We handle 2,000+ regulatory submissions every year.
✅ Flexible delivery: we can use your tools or ours, depending on your needs.

👉 Ready to accelerate your eCTD and global submissions with precision?
🔗 Learn more: https://www.makrocare.com/biopharma/regulatory/operations/publishing/

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/

Address

4 Independence Way
South Brunswick Township, NJ
08540

Telephone

+18889310060

Website

http://www.makrocare.com/

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