Manufacturers

RxChain – Manufacturers

 

FDA Compliance

At LSPediA, we like to understand your compliance requirements, goals, and challenges so we can recommend a solution that is best suited for your needs.  Fully committed to our clients’ success, we bring accountability and business value to every engagement. Please contact us for questions and RFQs.

DSCSA was signed into law on 11/27/2013, containing multiple deadlines of new regulatory requirements that get progressively more complex and difficult as time passes.  The first deadline was January 1, 2015, requiring:

  • All companies in the pharmaceutical supply chain to do business with authorized trading partners
  • All companies, except dispensers, to perform “product tracing” containing TI/TH/TS, also known as 3Ts
  • All companies to have a system in place to perform lot verification and suspect product handling
  • All companies to respond to requests for information from state or federal officials within 24 to 48 hours

LSPediA offers most comprehensive DSCSA serialization services. Please contact us for questions and RFQs.

 

Technology Services

Pharmaceutical companies face the challenges of running complex business operations while meeting the stringent and changing regulations. Regulation changes can significantly impact business operations. Keeping the operations efficient while adhering to regulations often times require new systems and processe including Product Tracing System, EDI, Serial Data Management, Warehouse Management System, Electronic Product Code Information System (EPCIS).

LSPediA offers technology solution and consulting services to define your technology architecture and system requirement, then implement it to ensure compliance and efficiency. Our experience and proven track record will help you achieve success in the cost effective manor. Please contact us for questions and RFQs.

 

 

Loading...