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.

๐ŸŽ„โœจ Merry Christmas from MakroCare! โœจ๐ŸŽ„As we celebrate this festive season, weโ€™re grateful for our amazing partners and te...
12/24/2025

๐ŸŽ„โœจ Merry Christmas from MakroCare! โœจ๐ŸŽ„

As we celebrate this festive season, weโ€™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 ๐ŸŽ๐ŸŒŸ

Seasonโ€™s Greetings from MakroCare! โœจ๐ŸŽ„Thank you to our amazing clients, partners, and team members for being part of our ...
12/17/2025

Seasonโ€™s Greetings from MakroCare! โœจ๐ŸŽ„

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! ๐ŸŽโ„๏ธ

High-quality medical writing is essential for compliant, submission-ready documentation.MakroCare supports Biotech, Phar...
12/16/2025

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

๐Ÿ“ Regulatory & clinical documentation
๐Ÿ“Š CSR, Protocols, IBs, SAPs, CER/PER, PMS plans
๐Ÿ” Scientific accuracy & evidence alignment
๐Ÿ›ก๏ธ Compliance with FDA, EMA, ICH & global guidelines
๐Ÿค End-to-end writing, QC, and publishing support

Strengthen your regulatory strategy with precise, audit-ready documents.
๐Ÿ”— https://www.makrocare.com/biopharma/clinical/medical-writing/

Ensure safer, user-friendly medical devices - backed by rigorous usability testing.At MakroCare, we help device manufact...
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:
๐Ÿงช Human factors validation
๐Ÿ‘ฅ User experience evaluation
๐Ÿ“Š Simulated-use studies & risk control
๐ŸŽฏ Clinical workflow fit & usability documentation

๐Ÿ›ก๏ธ Reduce use errors, accelerate approvals, and launch confidently with MakroCare.
๐Ÿ”— Explore more: https://www.makrocare.com/devices/technical/medical-device-usability-testing/

Need seamless, compliant regulatory submissions across geographies? At MakroCare, our experts manage eCTD-based filings ...
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 ๐ŸŒ.

โœจ We ensure:
๐Ÿ“„ Full compliance with global authority standards (FDA, EMA & beyond)
โฑ๏ธ Structured documentation, error-free submissions and fast turnaround
๐ŸŒ End-to-end submission management: from publishing to submission tracking, worldwide

Partner with experts - get your regulatory pathway right the first time.
๐Ÿ“Œ Explore more: https://www.makrocare.com/biopharma/regulatory/operations/sub-management/

Happy Thanksgiving from Team DDi! ๐Ÿฆƒ๐ŸToday, weโ€™re thankful for our amazing clients, partners, and global teams who inspir...
11/27/2025

Happy Thanksgiving from Team DDi! ๐Ÿฆƒ๐Ÿ

Today, weโ€™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! ๐Ÿงก๐Ÿฝ๏ธ

Happy Thanksgiving!

Bringing a medical device to global markets demands precision, compliance, and speed.MakroCareโ€™s Medical Device Registra...
11/25/2025

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

โœจ What we offer:
๐Ÿ”น End-to-end global device registrations
๐Ÿ”น Country-specific dossier preparation (EU, US, APAC, LATAM & more)
๐Ÿ”น Gap analysis & remediation
๐Ÿ”น 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.
๐Ÿ“Œ Explore more: makrocare.com/devices/regulatory/registrations-dossiers/

Ensuring CMC compliance across global markets is a challenge many BioPharma organizations face.MakroCare supports compan...
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.

๐Ÿ”น CMC Authoring (Module 2 & 3)
๐Ÿ”น Regulatory Strategy & Gap Assessment
๐Ÿ”น Change Control & Variations Management
๐Ÿ”น 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/

Are you navigating the complex regulatory landscape of Software as a Medical Device (SaMD) or IVD-software? ๐Ÿงฌ At MakroCa...
11/03/2025

Are you navigating the complex regulatory landscape of Software as a Medical Device (SaMD) or IVD-software? ๐Ÿงฌ At MakroCare, we partner with life-science organisations to deliver end-to-end regulatory, clinical and quality-services for SaMD/IVD products โ€” from submission strategy through post-market lifecycle. ๐Ÿš€

Our team brings:
โœ… Deep expertise in global frameworks (US, EU, Asia) ๐ŸŒ
โœ… Technical and clinical compliance support (software lifecycle, validation, documentation) ๐Ÿ“‘
โœ… Scalable solutionsโ€”whether full-service or functional modules to fit your needs ๐Ÿ”ง

Leverage MakroCareโ€™s proven track record to bring your software-driven medical innovation to market with confidence and speed.
๐Ÿ”— Know More: https://www.makrocare.com/devices/software-as-medical-device-samd/

Need audit-ready clinical documents that meet regulatory expectations โ€” without delays?Choose MakroCare Medical Writing ...
10/28/2025

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

Why Clients Trust Us:
๐Ÿ’ก Deep scientific & regulatory expertise
๐Ÿง  Skilled writers across therapeutic areas
โฑ๏ธ Quality delivery with quick turnaround
๐Ÿ“ˆ Supports faster approvals & submission success

Your data deserves to be communicated clearly.
๐Ÿ”— Letโ€™s get your documents submission-ready: https://www.makrocare.com/biopharma/clinical/medical-writing/

๐Ÿฉบ Post-Market Clinical Follow-up (PMCF) is vital for ensuring your medical device continues to perform safely and effect...
10/21/2025

๐Ÿฉบ Post-Market Clinical Follow-up (PMCF) is vital for ensuring your medical device continues to perform safely and effectively in real-world use.

โœ… MakroCare helps manufacturers design, execute, and document robust PMCF plans aligned with MDR requirements.
๐Ÿ“Š From data collection to clinical evaluation updates โ€” our team ensures compliance and confidence in your device lifecycle.

๐Ÿ”— Learn more: https://www.makrocare.com/devices/clinical/pmcf/

Ensuring nonclinical data integrity and global compliance starts with structured data standards.At MakroCare, we support...
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.

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

๐Ÿ” Letโ€™s make your data submission seamless and compliant with CDISC SEND best practices.
Know more ๐Ÿ‘‰ https://www.makrocare.com/biopharma/cdisc-non-clinical-send/

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4 Independence Way
South Brunswick Township, NJ
08540

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