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:


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

Case Studies
  • Portfolio Prioritization – Oncology

    Situation: A publicly traded Oncology company with 3 technology platforms and limited resources was in need of narrowing their focus. 


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  • Go-to-Market Strategy and Tactical Deployment Plan

    Situation: A privately held emerging biotech company, with an innovative cancer detection test, retained Kineticos to assist them in effectively


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  • 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


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  • Voice of Customer Study

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


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  • Go-To-Market Strategy

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


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  • Business Development & Licensing

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


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  • Are Checkpoint Inhibitors Impacting How We Cure Disease?

    Throughout September and October, we have been discussing Precision Medicine and it’s impact on various segments of the life sciences.


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  • Is Precision Medicine Impacting Innovation in Pharma?

    Shailesh and Alan finish their discussion with how there were speculation that precision medicine would reduce innovation in pharma. See


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  • Artificial Intelligence and Machine Learning’s Impact on Companion Diagnostics

    Shailesh and Alan continue their discussion on companion diagnostics and start thinking about how AI and Machine Learning are impacting


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  • Oncology, Rare Diseases, and Regenerative Medicine: Where does Companion Diagnostics fit in each

    Moving on from our Precision Medicine in Neurosciences, Kineticos’ Founder and CEO, Shailesh Maingi, talks with a diagnostics expert on


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  • Partnerships: Is Sharing Better for Precision Medicine in Neuroscience?

    Closing out our Precision Medicine in Neurosciences discussion, Nik and Jason discuss how various partnerships can impact the success of


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  • Biomarkers, Partnerships, and Companion Diagnostics: How will they impact the approval of Neuroscience Drugs?

    Continuing our Precision Medicine in Neuroscience discussion, Jason Kralic and Nik Tezapsidis discuss how biomarkers and partnerships will drive precision


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  • 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


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  • 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


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  • 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?


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  • 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


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  • 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


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  • 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


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