LuitBiz For Pharmaceutical Companies

4 Main Problems Faced By Pharmaceutical Companies


LuitBiz Built for Pharmaceutical Industry

Why should the Pharmaceutical Company choose LuitBiz?

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:

  1. Preclinical phase geared toward the submission an investigational new drug (IND) application - FDA regulations such as 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) and 21 CFR Part 312 (Investigational New Drug Application) requires effective pharmaceutical document management. 21 CFR 58 has specific document control requirements pertaining to SOPs for animal care, lab tests, data handling, and equipment maintenance and calibration; protocols; and handling of records, reports, and raw data documentation. 21 CFR 312 has its own set of requirements pertaining to recordkeeping, record retention, and investigator reports. Management of IND documentation is particularly crucial because it serves as the basis for other information that will be submitted to the FDA later.
  2. Pharmaceutical phase geared toward the submission of the new drug application (NDA) - In addition to GLP and GCP requirements that various teams must comply with, the sponsor also must manufacture the investigational new drug used for clinical trials in accordance with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Parts 210-211. GCP also includes guidance that call for effective pharmaceutical document management. Moreover, the sponsor must comply with 21 CFR Part 314 (Applications for FDA Approval to Market a New Drug) for its NDA submission.
  3. Commercialization, product launch and post-market phase geared towards mass production and marketing of the drug - Document control is a CGMP requirement and LuitBiz DMS ensures compliance with the regulations. In addition, the pharmaceutical or biotech company with a newly approved NDA must address post-market requirements found in 21 CFR Part 314, including the reporting of adverse drug experiences and the submission of NDA field alert report, annual report, distribution data, labeling, report on CMC changes, etc.

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.

LuitBiz - centrally manage all processes in Pharmaceutical companies - simplifies operations, boosts productivity

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