"For over 19 years, we've been supporting life sciences companies globally through importing/exporting assistance, quality assurance, supply-chain auditing, and regulatory compliance."
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Founded in 2008, Macorby leverages expertise in government, industry, and consulting. We have established subsidiaries and a global database, becoming a renowned global reference.
Documentation arrangement, customs clearance, and global market expansion support.
GMP/GLP/GCP compliance, quality management systems, risk assessment, and validation.
Sourcing high-quality Active Pharmaceutical Ingredients and excipients (binders, fillers) from GMP-compliant suppliers.
Full lifecycle support—from Pre-MA (dossier preparation, eCTD) to Post-MA (variations, renewals, XEVMPD).
Medical writing (Clinical/Non-clinical CTD modules), promotional material review, and toxicological reports (ERA, PDE).
QMS support, GxP training, supplier qualification, and risk assessments (Nitrosamines, Elemental impurities).
PSMF creation, Adverse event management, Signal management, and QPPV provision (EU & Local).
Global auditing services including Regulatory audits, Pharmacovigilance (GVP) audits, and GMDP audits.
Prioritizing co-worker motivation and professional training.
"Outside-the-box" approach and continuous legislative monitoring.
Establishing long-term, honest relationships and integrating into client teams.
"I highly recommend Macorby for their exceptional importing and exporting assistance. They have helped streamline our supply chain processes and have been instrumental in our global expansion efforts."
"Working with Macorby has been an absolute pleasure. Their attention to detail, professionalism, and reliability are unmatched. I couldn't be happier with the service they provide."
Ready to optimize your supply chain?