case study

Product Launch Plan

A generic pharmaceutical manufacturer was interested in applying lean principles to the operation of the Quality team, with the objective to reduce the product release timeframe. However, they lacked internal experience to embark upon this initiative.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Product Launch Plan

Background

A generic pharmaceutical manufacturer was interested in applying lean principles to the operation of the Quality team. The objective was to increase efficiency and reduce the product launch timeframe. However, they lacked new product launch experience to embark upon this release plan initiative.

Solution

The pharmaceutical company looked to the Regulatory Compliance Associates® Inc. pharmaceutical consultants to improve efficiencies in the manufacturing, batch approval and release plan to the distribution system.

The RCA experts used process mapping to identify redundancies, inefficiencies, and other opportunities inside the product launch checklist. In partnership with the company process owners, new processes were systematically developed and implemented. Employee departments involved included the Quality team as well as Manufacturing operations.

Result

The RCA experts reduced the 30 day process down to four days. This process improvement reduced the release plan time necessary for the company to retain costly inventory, allowing them to reduce investment by improving speed and reliability of product delivery to customers. This reduction in product release cycle time across multiple plants impacted the company’s cash flow, which internal experts estimated to be $50 million.*

By moving work-in-progress product more quickly into finished goods inventory, the company lowered carrying costs and floor space cost. By reducing the product release cycle time, the plant experienced less issues with back orders and short-dating. Additionally, for some export markets, the plant was able to ship product less expensively via boat instead of air.

*Cash Flow Improvement = product unit cost X # units produced/day X # days release cycle time improvement

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

Background

A generic pharmaceutical manufacturer was interested in applying lean principles to the operation of the Quality team. The objective was to increase efficiency and reduce the product launch timeframe. However, they lacked new product launch experience to embark upon this release plan initiative.

Solution

The pharmaceutical company looked to the Regulatory Compliance Associates® Inc. pharmaceutical consultants to improve efficiencies in the manufacturing, batch approval and release plan to the distribution system.

The RCA experts used process mapping to identify redundancies, inefficiencies, and other opportunities inside the product launch checklist. In partnership with the company process owners, new processes were systematically developed and implemented. Employee departments involved included the Quality team as well as Manufacturing operations.

Result

The RCA experts reduced the 30 day process down to four days. This process improvement reduced the release plan time necessary for the company to retain costly inventory, allowing them to reduce investment by improving speed and reliability of product delivery to customers. This reduction in product release cycle time across multiple plants impacted the company’s cash flow, which internal experts estimated to be $50 million.*

By moving work-in-progress product more quickly into finished goods inventory, the company lowered carrying costs and floor space cost. By reducing the product release cycle time, the plant experienced less issues with back orders and short-dating. Additionally, for some export markets, the plant was able to ship product less expensively via boat instead of air.

*Cash Flow Improvement = product unit cost X # units produced/day X # days release cycle time improvement

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.