Pharmaceutical manufacturers and wholesale distributors all face the challenges of complex regulatory compliance, tough customer demand, and high shareholder expectations. They 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
LSPediA Life Sciences Consulting Services
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 QMS, MES, and EPCIS: Strategy planning, request for quotation (RFQ), vendor selection, supplier audit, implementation, validation, project management, data analytics
We offer solutions for every part of your business – including serialization services, regulatory compliance, Technology services, and enterprise resource planning (ERP). Plus, our new LSPediA Serialization Toolkit will help ensure every stakeholder in every line of your business is equipped, trained, and prepared to implement a serialization process within your company. 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.