Pharmaceuticals

Product Lifecycle Management for Medical Devices and Pharmaceuticals

As a medical device manufacturer or exporter, you are constantly faced with challenges of managing product design and documentation, generating and maintaining records, training and knowledge dissemination, and complying with regulatory requirements defined by agencies, while constantly innovating on new products.

PROLIM Product Lifecycle Management (PLM) software provides a product-centric approach, equipping you with PLM capabilities and compliance using automated best practices and workflows enabling increased efficiency, reliability and the ability to configure new products faster.

Current challenges within the pharmaceutical industry is to focus on Product Lifecycle Management (PLM), which is a business transformation approach to manage products and related information across the enterprise. In recent years PLM has provided many pharmaceutical organizations with the ability to increase their ability to get products to market quicker, ensure greater regulatory compliance and efficiencies while reducing development costs. The Pharmaceuticals Industry faces three key challenges today:

  • Complex Drug Development Process
  • Large Gaps between R&D Operational Performance and Strategic Importance
  • Difficulty in managing Clinical Trial Inventories

To overcome all these challenges PROLIM offers PLM solutions for leading companies in the medical devices and pharmaceuticals industries, who recognize the need for a product lifecycle management (PLM) platform to answer their product development challenges. These proven and flexible solutions speed innovation in pharmaceutical and medical device development, reduce costs and help insure adherence to global regulations, including FDA compliance.

Benefits of Product Lifecycle Management for the Pharmaceutical Industry

  • Develops robust, transferable, low-cost formulation & manufacturing processes
  • Achieves product deliverables within new products’ project timelines
  • Enables planning and collaboration between the clinical and operations organizations
  • Delivers “right, the first time” Chemistry, Manufacturing and Controls (CMC) section in NDA dossier
  • Successfully scales-up and transfers process/technology to operations
  • Increases product intelligence to better determine probability of success earlier in the life cycle
  • Integrates internal and external systems to eliminate errors, improving operational agility and ensuring compliance
  • Tracks clinical and non-clinical performance in real-time to improve decision-making

PROLIM has provided tailored PLM strategy and implementation services to a number of Medical Devices and Pharmaceuticals companies that has helped them not only stay ahead of competition but also stay compliant with the federal regulations. We work with our partners’ PLM products to provide PLM solutions to increase business agility by streamlining product development processes to be in line with project goals and market requirements, by maintaining the traceability from product  cerebration to commercialization and devolution. The solution helps companies accelerate through the compliance process by integrating regulatory requirements with the product development process and filing for New Drug Application (NDA) approval to FDA.

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