Establish and run a cost-effective serialization program to achieve regulatory compliance.
"Global counterfeit drug market size exceeds $75B according to World Health Organization (WHO)."
The global pharmaceuticals industry is in the middle of major changes with regulatory requirements to improve supply chain security and patient safety increasing rapidly.
Currently, more than 50% of world GDP is under a final Serialization (Track & Trace) legislation, including countries such as US, Brazil, Argentina, China, Korea and Turkey. This number will exceed 80% very soon with the inclusion of EU member states and a few other emerging countries. All pharmaceutical companies should design their strategies, and get to project execution quickly, as the deadlines for these legislations are approaching fast. There are thousands of Pharmaceutical companies, however only a handful technology providers and consultants to support these major programs. Major leadership effort within the industry is needed to meet the challenges faced, and enable a smoother transition to a more secure supply chain, which will also improve patient safety.
You need to ensure regulatory compliance with various serialization legislations around the world such as US, EU, Brazil, China, India, Korea...and so on. Not being compliant, or being delayed, may significantly impact your market share, sales, profitability and your long term viability as a company. Your key objectives include:
- • Start your serialization program / projects
- • Ensure compliance with all countries/markets with serialization
- • Complete your program cost-effectively and on-time
- • Create synergies with other initiatives and generate value/ROI
Your Issues / Challenges:
Serialization (Track & Trace) programs are difficult in nature, and you are facing quite a number of challenges such as:
- • Organizational alignment & senior sponsorship
- • Very large scope (cross-functional, cross-country)
- • Very limited time (2015, 2016, 2017 deadlines nearby)
- • Limited resources (both capital and human resources)
- • Limited responsibility and ownership to get started
How Can We Help You?
Our team of expert consultants will partner with your organization to provide complete end-to-end Serialization (Track & Trace) support you need to achieve cost-effective compliance. We will bring world class expertise and support, and access to some of the most experienced Track & Trace consultants in the world.
Please go to each of the below services to see how we can help you successfully complete the serialization project phase by phase.