Case Studies

Preparing for Electronic Regulatory Submissions

A global pharmaceutical company needed to develop a new electronic document management system.

The Issue: There were conflicting views about selecting and installing a new system to manage its documents for regulatory submissions. There was also concern about the scope of the project. There was little time to reach consensus: the company needed to install the system before a key regulatory submission. It was also very short of internal resource.

The answer: The head of IT knew that RSA Consulting had in-depth experience in planning and installing electronic systems for document management. RSA placed a virtual team of specialist consultants in the US, UK and Belgium. They met senior executives and worked with project leaders to review vendor options and prepare a business plan. The consultants also highlighted an approach that could optimize the value of the investment. It meant including the manufacturing division’s requirements in the medium-term plan. They also prepared a report that compared the company’s position against industry benchmarks.

The outcome: The project leadership team agreed unanimously on vendor selection. The company leadership allocated sufficient resource to install the regulatory system successfully. A plan is now in place to use the same platform for the manufacturing division.

The bonus: RSA Consulting was able to fill the resource gap with a seamless service. It provided consulting, interim managers, executive search and contingency recruitment. The client was also able to minimise costs because RSA assigned the consultants to work in their own locales. This was possible because they all had experience working in global virtual teams.

Market Entry Assessment

A central European company approached RSA Consulting to evaluate the UK oncology off -patent market. It needed help in preparing a market entry strategy for its own portfolio.

The issue: The company needed to understand the size and market segmentation of the UK oncology market. It wished to assess market dynamics and regulatory barriers to entry. It also wished to understand

• the UK NHS procurement process
• the barriers to market entry
• who its competitors would be

The answer: The company engaged RSA Consulting to prepare a report. RSA identified and assigned a specialist consultant to the task. The consultant had a detailed knowledge of the commercial aspects of the oncology market. He also had an excellent network within the NHS purchasing community.

The outcome: The client company was now able to proceed with its market entry. It acquired detailed market information only available through expert knowledge of the UK NHS procurement process.

The bonus: The RSA Consulting delivery manager was an experienced management consultant and a pharmacist with experience in a major pharmaceutical company. She was able to support the specialist consultant and ensure that the report matched the client’s specific needs.

Science Advisory Service

A global venture capital company wanted access to senior experienced sector experts. It needed help in assessing investment options.

The Issue: The company needed senior experience across a range of scientific and commercial activity. The range was beyond the compass of a single individual. The company had previously worked with venture partners but found that their requirements were changing rapidly. The range of investments that they were considering required access to a multi-skilled team of senior experts.

The answer: RSA Consulting proposed a science advisory service. This provided access to a network of relevant qualified senior sector experts. It allowed a virtual team with scientific, commercial, strategic and functional skills to work together. The team was able to respond rapidly to the changing requirements of each investment decision. RSA became the preferred partner in assembling a team with the correct experience. By varying the membership of the team it could adapt to the content of each project.

The outcome: The company could move rapidly beyond initial financial assessment of potential investments. It could:

• evaluate intellectual property development strategies and market entry choices
• perform informed due diligence on intellectual property and business worth

This enabled better evaluation of investments and a more detailed business plan for new start-up companies.

The bonus: RSA Consulting was able to maintain a network of relevant consultants. It was also able to identify other experienced candidates to provide additional support as the project needs developed. The teams were then in place to continue to offer an informed and responsive service.

Portfolio Management

A global venture capital company required additional input from sector experts to:

• assess its portfolio companies and
• devise growth strategies to enhance the returns on their investments

The Issue: The company had a portfolio of investments that included start-up and early-phase firms. In most cases the firms had launched successfully but needed help in:

• reviewing their business plans
• identifying faster growth opportunities
• assessing more valuable exploitation strategies

The answer: RSA Consulting provided a consulting services board. This was a network of senior sector experts with experience of business start-up and growth. This allowed a multi-skilled team approach. It also allowed wide consideration of options for:

• new business development
• refinement of the business model
• developing new products

The outcome: The company was able to identify new options for its portfolio companies. In most cases it found more valuable routes to market and more robust business models. It was also able to manage the use of funds to:

• drive new growth
• obtain better information to support second-round funding

The bonus: RSA Consulting was also able to provide support on human resource planning. It helped to:

• select and recruit experienced staff
• provide interim support for development projects
• identify non-executive director candidates with excellent knowledge of the portfolio companies