It’s an understatement to say a lot has changed in our industry in the last 10 years. Comparing the pharma and biotech landscape of 2006 to that of 2016 isn’t like comparing different worlds – it’s like comparing entirely different time-space dimensions.
Having consulted with pharmaceutical clients large and small, I’ve seen the changes first hand: New standards and mandates are straining resources and budgets, and market conditions are changing faster than ever, throwing almost everyone off balance.
LSPediA: Pharmaceutical Services for Better Business Outcomes
My clients all face the challenges of complex regulatory compliance, rising customer demands, and high shareholder expectations. Having worked with a diverse group of stakeholders from across these organizations, I’ve come to see that they all share similar obstacles in their pursuit of those goals:
- 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
Those are tough issues, especially in combination. But with the right services, solutions, and a reliable guide, you can bring coherence, efficiency, and direction to your pharmaceutical business. […]
Click the above images for a description of each kit
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:
- Regulation translated to English
- Business impact assessment
- Strategy and roadmap
- Packaging Specification
- CMO Specification
- 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:
- Built out standards
- Best industry practice
- Risk mitigation
- Develop well-trained, qualified employees faster
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
- Budget planning
- Online or in-person training
- Implementation and project plans
“What I appreciate about LSPediA is the flexibility and accessibility. I know when I call Riya, she is going to be at the other end of the phone.”
“We had multiple changes in scope and we were still able to deliver on the 2015 requirements which was a great achievement.”
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