Gain New Efficiencies and a Competitive Edge with the Right Services Provider

By January 20, 2016 April 30th, 2018 DSCSA, Serialization, Toolkits

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.

LSPediA Services – What We Offer  

LSPediA helps you overcome obstacles through a suite of services covering a wide range of needs, including:

  • Serialization services: Strategy planning, gap analysis, process design, RFQ, vendor selection, implementation, Electronic Data Interchange (EDI), validation, project management, contract manufacturing organization (CMO) management
  • Regulatory compliance: Compliance gap analysis, GxP, QSR, Part 11, and ISO13485, compliance remediation, style audit, audit report and compliance letter, SOP library, regulatory advising. QMS process and implementation, computer system validation
  • Technology services: Process/workflow analysis, requirements definition, recommend system design and integration, review and present industry solutions, qualify vendors, manage software selection, create implementation plan, validation services, training, go-live support, IT advisory service, audit IT compliance
  • Enterprise resource planning (ERP), plus PLM, QMS, MES, EPCIS, and LIMS: Strategy planning, request for quotation (RFQ), vendor selection, supplier audit, implementation, validation, project management, data analytics

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We’ve also just released our LSPediA Serialization Toolkit to help you meet upcoming Drug Supply Chain and Security Act (DSCSA) deadlines. The Toolkit can help ensure every stakeholder in every line of business is equipped, trained, and prepared to implement a serialization process within your company.

LSPediA Services – How You Benefit

My time as a consultant in the industry has given me deep insight into solving difficult business problems. 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

To find out how we can give your company a competitive edge, contact me today. Working together, we’ll develop a customized LSPediA Services plan that’s just right for your business.

Ed Patel, Director Metrics Contract Services, Mayne Pharma

“LSPediA makes life a lot easier for me managing the ERP project. Working with LSPediA is like having a tour guide that goes a step above, they are a partner and they’re in there working with you.”