No industry is more regulated than CPG. Always searching for ways to improve the condition of precious human lives, medical device, pharmaceutical, biotechnology and patient care companies are proactively engaged in self-monitoring of its product quality issues. Given the increasingly stringent government regulations and potential lawsuits from consumers, the costs and risks associated with inconsistent product quality and non-compliance are simply too great. Progressive companies are relying more and more on Product Lifecycle Management solutions to address the key challenges
- 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
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 Â 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.