Case Histories


Drug Product Stability Issue

Our client had reduced a drug product's expiration dating because of results of stability tests.  The product was a critical source of income to the client and an answer to the problem was needed quickly.  Our consultant reviewed laboratory practices and analytical methods and introduced proper statistical analysis to the Quality Assurance team performing drug stability review.  The result was a proper scientific defense for extending the expiration date back to the original product shelf life.  Our consultant worked with the client to create a more permanent solution to the problem by installing software and validating the computer systems for Part 11 compliance.

Our consultants strive to respond quickly to your needs with long-lasting solutions to root causes so that issues do not reoccur.


Improvement of Drug Product Filling Process

Pricing pressures had shown our client that it was time to improve a wasteful process. The product accounted for 20% of the company's income.   An automated filling process was causing overfilled containers because the overall variance of process was too high.  Our consultant used Six-Sigma tools to isolate the critical factors in the process and reduce process variance while teaching Six-Sigma methods to a key production engineer at the client's manufacturing site.  This helped to prevent erosion of the company's margins and taught them a few tools to use when other process improvement projects surfaced.

Our consultants are trained in the most recent techniques for problem solving and process improvement so that we can assist our clients make improvements that have direct impact on the bottom line.


FDA 483 Trouble

A pharmaceutical manufacturer had contacted us regarding a recent FDA inspection.  They had numerous inspection findings listed on FDA Form 483.  A possible product recall and the approval of several product submissions hung in the balance.  The majority of the problems came from an ineffective quality system.  Our consultant assisted the client's Quality Assurance Department in re-engineering the quality system processes so that a timely response to the problems could be sent to FDA.  We also researched and formulated a unique regulatory strategy that prevented the recall of the drug product.  Subsequent FDA inspections resulted in 95% fewer findings and ultimately inspections with no Form 483 written.

Many times we have seen lack of compliance resulting from inefficient and cumbersome quality systems.  Streamlining these processes can lead to improved compliance and lower operating costs.


CMC Section for New Drug Application (NDA)

Our client had purchased a new drug product that had not yet been submitted to FDA for approval.  A similar competitor product was also getting close to approval and our client's submission needed to be finished and submitted as quickly as possible.  Our consultants integrated quickly into the product submission team helping to determine the remaining scope of work and assuming roles in the development of the CMC section.  We created collaboration tools using our shared web server to integrate the submission writing from remote sites and other suppliers. After submission, the library of information built up on the shared server allowed the team to respond quickly to the questions posed by the FDA.

We specialize in the ability to coordinate the work of associates from remote sites in accomplishing our client's goals.  We can assist with writing submissions or designing quality systems utilizing the talents of other associates who may not be located in the same facility, city, or country.  This allows us to bring many talents to each consulting situation.