LSPediA News

E.U. Serialization and U.S Serialization: Four Differences and One Big Similarity

shutterstock_106097018The Falsified Medicines Directive – the overseas cousin of our Drug Supply Chain Security Act (DSCSA) that protects the European public from counterfeit, stolen, expired, and recalled drugs – became law this past January. It sets in motion a number of requirements for pharmaceutical manufacturers, distributors, and wholesalers doing business in the 28-nation E.U. It’s […]

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Serialization Toolkits


 What is included?

Each toolkit covers a specific country’s essential serialization requirements. No matter which toolkit you choose, you will always receive the following features:

  • Regulations translated to English and business impact assessment
  • Gap analysis, strategy, roadmap, and IT infrasturcture template
  • Bottle, bundle, case, pallet serialized label template in GS1 standard
  • Packaging and CMO Specification
  • Line execution plan and deliverables schedule template
  • Class room training, online training, and training Videos

 Why Use a Toolkit?

By selecting one of our Serialization Toolkits, your company can rest assured knowing that you are getting the best possible training on serialization while saving time, energy and money:

  • Lower overall serialization spending by reducing the number of redesigns – the Serialization Toolkit ensures you get it right the first time
  • Mitigate compliance risks with comprehensive, gapless coverage tailored to your specific needs
  • Shorten your project timeline by removing trial-and-error process
  • Develop employees by provide training to operations, supply chain, IT, quality, and customer service

 Tailored for Your Business

All of our Serialization Toolkits come custom-tailored to meet your business’s needs. Serialization strategy, training and execution can be specialized in way that makes sense for you:

  • Strategy & roadmap customization
  • IT infrastructure build out
  • URS and RFQ generation
  • Online or in-person training
  • Implementation and project plans

 

Customer Testimonials

 

 I would seriously recommend LSPediA. Their leadership has been awesome. Their project management skills have been terrific. The expertise and knowledge around Manufacturing, regulations, serialization, integrating systems has been incredibly valuable to us.

Ken Riester, VP Supply Chain, Kowa Pharma

I have been working with LSPediA on the DSCSA Serialization Project. LSPediA kept us focused on the timeline and objective and made sure we knew what the future looked like for DSCSA.

Karen Lane, Controller, Mayne Pharmac

We don’t have a staff large enough with the sufficient knowledge and experience to take on a serialization project on our own, so we utilized LSPediA’s knowledge and now we basically have the workforce and knowledge of a much larger company because of it.

Brad Allen, IT Director, Kowa Pharma

 

Consulting Services

For pharmaceutical manufacturers and distributors who face the challenges of:

  • Regulatory complexity –DSCSA, GxP, CFR 21 Part 11, etc.
  • Technological hurdles – New solutions, Legacy systems, IT staff shortages, security concerns
  • Operational inefficiencies – Communication silos, supply chain disruptions, inventory control

LSPediA offers a suite of services covering a wide range of needs, including:

  • Serialization services
  • Regulatory compliance
  • Technology services
  • ERP, EDI, Warehouse, EPCIS

Here are just some of the ways our clients are benefiting from LSPediA Services:

  • More efficient business processes
  • Better return on technology investments
  • Improved regulatory compliance
  • Higher customer satisfaction
 

Webinar Archive

webinar1

Global Serialization 1 of 3: Global Serialization Overview

With some deadlines behind us, some approaching, and many more on the horizon, we’ll take a look at the global serialization landscape including that of Brazil, China, South Korea, US, EU and many more. View this webinar to hear discussions on the lessons learned from past implementations and learn the upcoming deadlines and what they entail.

– Global Regulations

– Past deadlines

– Upcoming requirements and deadlines

– Key implementation building blocks

– Lessons learned

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