In the bio-pharmaceutical and medical device industries, the management team’s top priorities focus on striving to minimize product development time, time-to-decision and time-to-market, managing cash burn, and meeting regulatory mandates.  While these issues are universal, they are especially magnified in emerging and mid-sized companies.  These companies have limited resources, gaps in expertise, immature business processes, and the burden of regulatory controls.

For these areas, large companies have a distinct advantage over smaller companies in that they are capable of contracting expensive integrators and investing in multi-million dollar enterprise applications to drive improvement in key processes like Product Development, Quality Management, Capital Delivery, and Regulatory Compliance. But for smaller companies, these enterprise solutions are overkill and the design and implementation of these systems distract the organization from their mission at large. Adding to the problem, there are no user applications that provide sustainable improvements to business processes of smaller bio-pharmaceutical companies.

 To compensate, one of the key strategies smaller companies can leverage is the use of outsourcing firms, contractors and consultants.  Today we are seeing more and more companies operating “virtually” by contracting out most of their operational and quality challenges.  In the past, you could have a company that may have been 80 to 100 people.  Today, many of these companies now operate at 8 to 25 people and are still successful at taking a product to licensure. 

 With that being said, these smaller, virtual companies must define, operate and assess all of the processes as if they were much larger.  The key challenge for companies this size is that you still need to go through all the steps of developing an organization, qualifying contractors and consultants that meet your requirements, clearly identifying what the goals are, what the quality aspects are, what the specifications are for a product and then tracking that all the way through the process of licensing a product.   

In addition, one of the most important areas is in the alignment and management of the expectations, the goals, and the milestones of an organization.  Many times, these are not commonly known throughout the company’s management.  To get to the goal, we find that we must align senior management and all the group managers to a common milestone.  To help companies stretch resources and budgets further and allow them to become fast, fierce competitors in the highly regulated Bio-Pharma sector, V2 Bio-Consulting and Alinion are offering an innovative solution that combines industry expertise with cost-effective, service-based software.  V2 Bio-Consulting and Alinion Inc. have partnered to bring an affordable, web-based solution designed to drive your organization's transition from risky improvised activities to effective processes that can be measured and managed for continuous improvement. In addition, our solutions will help companies be more efficient and increase performance in presenting and maintaining regulatory compliance.

Using our Process Suites, clients can adopt standards and implement processes that have been developed and proven through our combined technical and Biopharma experience These Process Suites establish and organize processes, maximize work team productivity, support adherence to compliance mandates, provide assurance that critical requirements are met, and increase your company’s visibility into its core programs, procedures and processes. 

For more information about V2-Bio-Consulting and this blog, contact Kurt Vorheis at kurt@v2bio.com.