In a pharmaceutical company, the job of translating a scientific idea into a safe medicine that benefits millions of people is a long, difficult, and expensive process. This process takes 10 to 15 years at a cost of $800 million to $1 billion to bring a new drug from a laboratory to a pharmacy shelf, according to the Pharmaceutical Research and Manufacturers of America (PhRMA). This expensive process involves a whole bunch of documents and regulatory compliances that need to be adhered to and also readily available for reference. The Document Management and Business Process Management Modules of LuitBiz can be very useful for Chemical and Pharma companies to manage all their documents and design and create their SOPs.
A pharmaceutical company who obtains a limited number of years patent at the start of its discovery process takes around 55% of the number of allocated years to develop the drug and get it approved by the FDA. Taking this period out of the allocated number of years of exclusivity under the patent would leave the company only 45% of the number of years to capture the full value of its product before generic competitors enters the market. When its competition enters the market, the company loses its market share considerably which increases with each passing year. Additionally, unavailability of requisite documentation produced during the development phase result in much more waste of time and money for the pharmaceutical company. Luitbiz DMS with its easy to use features can prove to be a boon to pharmaceutical companies in this aspect. Drug development is a very document intensive job. From the scientists leading the drug discovery process to the marketing specialists writing a new drug's labelling - they all need to document their activities for a variety of reasons. More importantly, they need to control or manage their documents. So any delay caused by poor pharmaceutical document management could affect overall time to market.
The development and marketing of a drug by a pharmaceutical company involves the following 3 steps:
LuitBiz DMS & BPM can help pharmaceutical companies in each of these phases by providing a solid foundation for effective document control and SOP generation that will help accelerate overall time to market by simplifying workflows, promoting efficiency, and making compliance easier.
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