Biopharmaceutical Practice Regulatory

Our Regulatory services are designed to help biopharmaceutical companies to solve complex regulatory challenges, as well as reduce risk and expedite the development process, by applying a premier level of expertise to every client engagement.

Service Lines Include:

5


Click the Tabs Below for Case Studies, White Papers, and Articles

Case Studies
Articles
Blog
  • Diagnostics Partnering Support

    Situation: An emerging oncology diagnostics company was in need of a Business Development strategy and retained Kineticos to develop such

     

    Read this Case Study

  • Voice of Customer Study

    Situation: A joint venture between two European companies was looking to maximize the commercial potential of its automated plate reader

     

    Read this Case Study

  • Go-To-Market Strategy

    Situation: As a follow up to a pricing study, Kineticos was retained by a specialty laboratory to develop a comprehensive

     

    Read this Case Study

  • Oncology Commercial Assessment – Melanoma

    Situation: A clinical-stage oncology company with a potentially ground-breaking technology requested Kineticos to help determine which tumor type(s) had the

     

    Read this Case Study

  • Business Development & Licensing

    Situation: An innovative oncology diagnostics company retained Kineticos to assist in developing their pitch deck, as well as developing and

     

    Read this Case Study

  • Product Search

    Situation: A drug delivery technology company identified an opportunity to generate additional revenue by acquiring products to further develop and

     

    Read this Case Study

  • Board Meeting Participants: Exclusivity Equals Productivity

    Last week, we published an article related to how board members can be sure to earn and hold on to

     

    Read this Article

  • A Guide to Being a Good Board Member

    Our focus for the month of June is on biotech boards.  Last week, we published a piece on putting together

     

    Read this Article

  • 8 Key Principles to Building a Board of Directors

    There are too many great ideas that never reach the surface in our industry and that’s where Kineticos’ newest family

     

    Read this Article

  • Will Technology Solve Our Biggest Challenges?

    We’ve come a long way in drug development over the past 20 years but we are still in the early

     

    Read this Article

  • A CRO’s Role in Innovation

    It was once solely on the shoulders of Pharma/Biotech to produce all of our industry’s innovation. However, we’re learning that

     

    Read this Article

  • Where is Today’s Innovation Bottleneck?

    Where is Today’s Innovation Bottleneck is the second installment of our 4-part series related to a recent statement issued by

     

    Read this Article

  • How Metrics Can Help Identify and Solve Operational Challenges

    Article Preview As the sophistication of operational practices across life sciences increases; unfortunately, so do the difficulty and complexity of

     

    Read this Blog Post

  • Growth by Acquisition in Life Sciences: Do You Have a Plan?

    Article Preview As the life sciences landscape continually changes, growth by acquisition has become increasingly common. Recent deals, such as

     

    Read this Blog Post

  • R&D Revolutionaries: Why the Actavis/Allergan Deal Takes a Stand for Biopharma’s True Roots in Innovation

    James Forte of Kineticos takes an in-depth look at the recent Actavis/Allergan deal including the role R&D innovation played in shaping the deal’s outcome. Let’s be candid. It’s been awhile since any biopharma company was able to claim R&D as a core competency with a straight face. Biopharma’s R&D efforts have long been challenged, and rightly so given its output, but the Actavis/Allergan deal shows that the right investment in R&D can revolutionize a business. Could efficient R&D be the new definition of innovation?

     

    Read this Blog Post

  • Driving Revenue and EBIDTA at CROs through Customer Loyalty

    Article Preview Determining customer satisfaction and loyalty is a difficult endeavor for most businesses. Traditional voice of customer surveys are

     

    Read this Blog Post

  • Merck KGaA and Bayer Choose Opposite Strategies

    Article Preview Europe’s two largest chemical and drug conglomerates are changing course in starkly opposite ways. As reported in recent

     

    Read this Blog Post

  • Next Generation Sequencing: Using Technology to Develop Mutually-Beneficial Partnerships

    Article Preview Arup Laboratories announced it will begin offering next-generation sequencing (NGS) based high resolution Human Leukocyte Antigen (HLA) genotyping

     

    Read this Blog Post

Subscribe to our internal think tank, Kineticos Research Institute