Good Manufacturing Practice is critical and not just a legal requirement that enables Manufacturers to locate the balance between optimal maintenance and maximum productivity, while also ensuring that the patient receives the correct medication with no compromise to safety, quality and efficacy.
Compliance reduces risk, promotes safety, fosters trust, and forms our ethics.
With the implementation of the Falsified Medicines Directive (FMD), medicine serialisation has become a cornerstone of pharmaceutical regulation in Europe.
Our team offers expert guidance to navigate the complexities of FMD compliance, including the integration of unique identifiers and anti-tampering devices, as well as the establishment of robust data management systems to facilitate traceability across the supply chain.
In the United States, the Drug Supply Chain Security Act (DSCSA) mandates the implementation of serialization and traceability measures to enhance drug safety and accountability.
Our company offers comprehensive support to pharmaceutical stakeholders in navigating DSCSA requirements, from establishing standardized product identifiers to facilitating electronic data interchange (EDI) with trading partners, thereby enabling compliance with U.S. serialization regulations and fostering trust throughout the supply chain.
In the Middle East, countries are increasingly adopting medicine serialisation requirements to safeguard public health and combat the proliferation of counterfeit drugs.
Our consultancy services are tailored to assist pharmaceutical companies in the Arabian Peninsula in adhering to local regulations, such as Saudi FDA’s Drug Track and Trace System, ensuring seamless compliance and uninterrupted access to regional markets.
As Kazakhstan moves towards enhancing its pharmaceutical regulatory framework, including the implementation of medicine serialisation standards, we can offer specialized support to navigate the evolving landscape.
From advising on compliance with the National Information System of Drug Circulation (NISDC) to assisting with serialization data exchange protocols, we empower pharmaceutical entities to meet regulatory requirements efficiently and effectively.
The Russian pharmaceutical market presents unique challenges and opportunities concerning medicine serialisation compliance.
Our consultancy services are designed to guide companies through the intricacies of Russia’s Federal Law on Circulation of Medicines, facilitating the integration of serialization solutions and interoperable data exchange systems to ensure compliance with local regulations and optimize supply chain transparency.
With deep experience in pharmaceutical serialization, we excel at aligning the four pillars of success: technology, process, people, and audit. Our holistic approach optimizes compliance while fostering trust in your systems and results.
Built on global standards, our solutions ensure reliability and consistency. By combining universal foundations with expertise in local regulations, we deliver region-specific compliance without compromising simplicity.
From assessment to deployment and ongoing optimization, we guide you through every step of your compliance journey. Our partnership ensures continuous improvement and peace of mind.
Our collaboration with leading technology providers ensures access to innovative, seamlessly integrated solutions that enhance your operations and scalability.
We prioritize quality, integrity, and results, delivering solutions that enhance efficiency, reduce risk, and provide tangible value—ensuring your systems are built to perform.
Our scalable, adaptable solutions anticipate tomorrow’s challenges, keeping your serialization ecosystem robust and future-focused so you can concentrate on growth.
Contact us today for a tailored consultation.
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