The LinkLab Information

Companies need to be prepared to meet the US 2013 Drug Supply Chain Security Act (DSCSA) (http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm) and coupled with differing requirements for other countries that continue to evolve, it makes for a very complex environment to ensure compliance. There are also opportunities, as companies and trading partners get systems in place, to understand how this increased ability to trace products can not only decrease counterfeit and improve security, but is there business value to be found as well. We can customize our support to best meet a company's needs, but some of our general offerings: - Serialization Strategy Assessment / Roadmap: We can assess current programs or develop roadmaps for companies that ensures best practices for serialization implementation and vendor selections. - Serialization Project or Program Management: We have experience driving integrated teams (both in-company and virtual): IT, Quality, Supply Chain, Commercial, Artworks, Distribution, etc. to ensure compliance before the FDA deadlines. - Business Value Identification: Most in industry have spent the last few years figuring out how little they can do to be compliant. We actually think it is important to figure out how the future world will work, and identify how serialized, traceable product can add value to your business. - Vendor Assessment: We have worked with many of the vendors providing services for serialization; as more companies start implementing, we know they will become the critical path for many. We can help navigate the landscape and ensure companies pick partners that match their needs and deadlines.