Successful New Industry Expansion
July 7, 2010
by Andy Mangano
Client Situation:
A tier one automotive supplier was looking to diversify their revenue stream and product offerings by expanding into the fulfillment of sample medications and literature for the pharmaceutical industry. Their expansion was enabled by partnership with a third company. 
The challenge was to maintain the company’s preferred supplier status within the automotive industry while cost effectively setting up the processes and procedures to support their expanded business plan. Res Partner’s led the identification and implementation of the new business process and associated regulatory filings needed. This included the initial filing within the controlling state along with supporting the filing of licenses within all 50 states.
What We Did:
In order to establish a base understanding of what tasks needed to be implemented an audit of the facility was conducted along with their existing procedures (the organization is ISO certified). In conjunction with the senior management team a project plan with key deliverables was drawn up and agreed upon. The Res Partner’s Consulting Principal then conducted a training program in order to educate the organization on:
- the new business process for fulfilling pharmaceutical samples and literature
- what the regulatory agencies would require; and
- a perspective on pharmaceutical clients would expect.
The next step was a detailed physical audit of the location, which resulted in recommendations to corrected noted deficiencies in the facility. These recommendations were approved and implemented within the building. In addition, the current organization and its competencies were reviewed and subsequent recommendations were made for required organizational changes. Once this was accomplished the organizations current process flows were reviewed to ensure the organization continues to maintain their ISO certification. We then established a base of required process a flows and Standard Operating Procedures (SOP’s) that had to be written and approved. The Res Partner’s Consulting Principal generated these necessary documents to maintain the ISO certification. Once completed these documents were reviewed and approved by the company’s management team, they were communicated and implemented throughout the organization. Our last set of steps was to submit the proper paper work with the state, which was coordinated by the Res Partner’s Consulting Principal, and the actual audit scheduled for the organization.
Results:
The organization successfully passed the audit conducted by the state and they were granted their pharmaceutical distribution license, at the end of audit, by the inspector. The state inspector made a strong recommendation that other organizations should follow this company’s lead on how to operate. A Res Partner’s Consulting Principal coordinated the filings for the other state licenses’ and the company is in final negotiations for their first supply agreement.
Improving Compliance At A Global Life-Science Client
July 6, 2010
by Chris Wubbolt
Client Situation:
A large, global pharmaceutical company determined its product complaint handling program was inefficient and considered a significant compliance risk by the Global Quality Management organization. Over 1000 product complaints were past due and the existing organization did not have basic tools in place to maintain a compliant quality system. The instructions describing how product complaints were to be handled were split into 12 different, often contradictory Standard Operating Procedures (SOPs). The product complaint group did not have a method or system to track due dates for investigating and closing product complaints, and the personnel within the department did not work together as a team to assure organizational objectives were met.
The client asked us to analyze their existing processes, systems, procedures, and personnel; provide recommendations for improvement; and implement the recommendations. The project required us to meet tactical business needs (e.g., investigating and closing new and existing product complaints) as well as address strategic initiatives, such as implementing a sustainable, effective product complaint management program.
What We Did:
We first focused on assuring existing product complaints did not pose a threat to product quality or patient safety. Therefore all existing complaints were assessed and prioritized based on their potential severity. Next, we prioritized based on the “age” of the product complaint. All product complaints were entered into an interim spreadsheet that was used to track their status. 
In parallel, daily “stand up” meetings were held to discuss the status of new and existing complaints and to assure product complaint team members were working together to reduce the existing number of overdue product complaints.We then developed functional flow charts to identify the “AS IS” product complaint process. Using appropriate metrics we identified inefficiencies within the existing product complaint process, which may adversely impact product quality, patient safety, and compliance. A “TO BE” functional flow chart was developed based upon input from the various stakeholders involved in the product complaint process, including manufacturing, distribution, quality control, and regulatory affairs.
The TO BE functional flow was used to develop a single, unified SOP which defined the new product complaint handling process. The functional flow charts were also used as input into a User Requirements Specification (URS) for a computer system which was implemented for entry, tracking, trending, and reporting of product complaints. A URS is required by regulatory agencies and identifies the “intended use” of the computer system. The computer system was implemented and validated in a manner fully compliant with regulatory requirements. A second SOP was developed to describe the operation and maintenance of the computer system.
Results:
The project resulted in some pretty significant results:
- Within 4 months of project completion the product complaint backlog dropped from 1000 overdue complaints to 100 complaints (open 30 days or less).
- The myriad of existing, contradictory and non-compliant SOPs had been reduced from 12 to 2.
- A new, fully compliant computerized system was implemented to manage the product complaint process. This system later became a model for the global product complaint handling system.
- Most importantly, the product complaint team gained new work skills and practices which allowed them to sustain the levels of compliance achieved.
Rescue after Sudden Loss of CFO
June 26, 2010
by Rose Fisher
Client Situation:
An international not-for-profit professional society found that it’s Chief Financial Officer was leaving for a new position after 20 years with the organization. With very little notice and nobody on the bench, the Executive Director was in a bit of a spot. Nobody was familiar with the antiquated systems or processes in the Finance Department. Year end and the annual audit were fast approaching. They needed an experienced person who could “hit the ground running” with very little training. The two fold problem was not only to close out the year, produce year end financials and work with the outside audit firm to complete the required audit, but to also search, help select and train the new permanent CFO.
What We Did:
Within two days of meeting the Executive Director we placed a senior financial executive at the client site for two weeks with the outgoing CFO. After just two weeks of basic process training we took over the financial function for the multi-million dollar international society. During this time period we learned and understood the marketing, sales, internal systems and financial functions. We successfully closed out the fiscal year, prepared year end financials and worked with the outside audit firm to complete the required annual audit. During our tenure we discovered many areas for improvement in the systems and processes, since the incumbent had been employed for such an extended period of time many systems were never upgraded. Within five months of taking over the Finance function, we completed a successful search for the right CFO candidate, who met all the specifications for the position. Our senior staff than trained and mentored the incoming permanent CFO over the next few months. During this time frame we also worked on several projects to update and improve the reporting functions with new software and re-trained the existing staff.
Results:
Within one year of becoming the Interim CFO we successfully completed several projects for this client. First, we managed the Finance function on an interim basis, oversaw the transition, and found and trained the replacement CFO. Second, we updated the client’s accounting software, integrated the new software with the front end agency management software, and trained the existing staff on the new systems. Third, we streamlined the audit process and engaged a new audit firm. There were also several smaller ad-hoc projects completed along the way. The software update and streamlining produced a 20% improvement in the time required to complete the annual reporting. It also streamlined the associated processes so the CFO could handle additional duties and work more closely with the Executive Director on several management issues that arose during our tenure. The society and its Board were extremely grateful for the speed and efficiency in which we were able to grasp their systems and processes and improve them as we handled the immediate need for an Interim CFO.
Born in the USA (Reprint)
November 5, 2009
by Avik Roy & Ilene Chunko Magazine Cover Table of Contents
The Micro Cap Review October 2009 Edition
Born in the USA - Page 1
Born in the USA - Page 2
Business Expansion Challenges
October 17, 2009
by Carol Stuckley
Client Situation:
A successful life sciences entrepreneur was lured into expanding his global business into a new, higher fixed cost, lower margin and higher risk business segment, with the further complexity of adding multiple international locations. Exacerbated by the global economic slowdown, this business segment expansion increasingly gobbled up cash, eroded margins and depressed earnings.
What We Did:
RES Partners identified opportunities to augment margins in the new business segment by identifying new services and applying premium pricing to niche projects where competition was de minimus. Additionally, contracts were revamped to comprehensively reduce business risk and improve cash flow. International operations were streamlined to eliminate inefficiencies. Importantly, this successful entrepreneur learned to say “no thanks” to new business opportunities that could not meet his newly defined risk/reward threshold.
Results:
This successful entrepreneur was able to arrest the cash drain attributable to his new business segment expansion, simplify his international footprint, improve profit margins and protect his legacy as a successful entrepreneur.
Finding Best Revenue Growth Opportunity
July 16, 2009
by Avik Roy
Client Situation:
A small, fast-growing, clinical research services company had diversified their investments, but had no clear guidelines for prioritization, hindering execution.
What We Did:
RES Partners developed a growth strategy that could focus the company’s energy and effort, and guide capital-efficient growth investments. Working closely with internal and external experts to analyze target markets, opportunities, risks, and capabilities, we provided scenarios of how the company could enhance their competitive advantage and revenue growth potential. The opportunities were structured into distinct and viable strategic themes and we engaged with the senior leadership team to formulate key decisions with strong buy-in.
Results:
The service company quickly established a clear growth strategy embraced by every member of the leadership team. As a small company, the decision to concentrate limited resources on the most strategic growth opportunities gave the leaders the clarity, conviction, and confidence to execute effectively.
Finding Customers and Channels with
Growth Potential
Growth Potential
July 16, 2009
by Avik Roy
Client Situation
A recently launched personal care product with a go-to-market strategy focused entirely on using direct marketing channels.
What We Did:
RES Partners identified alternate sales & marketing channels that would effectively reach target customer segments. Research was required to clearly define the target customer segments and channels, including some that were not originally on the company’s radar. To provide greater focus and prioritize resource allocations, we worked with the client and narrowed a list of 25 targets to the top four. Upon further analysis, the four channels were ranked by revenue and profit potential over three-year timeframes.
Results:
The CEO was able to make a clear choice and is now negotiating a partnership with one of the top players in the newly identified channel that would multiply sales while significantly lowering customer acquisition costs.