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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.

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Case Studies
Articles
Blog
  • Business Development Support

    Situation: An innovative, privately held life science company retained Kineticos to assist in developing their pitch deck, as well as

     

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  • Commercial Assessment

    Situation: A mid-sized biotech company evaluating their Phase II Metabolic asset requested that Kineticos provide a commercial and financial assessment

     

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  • Tradeoff Analysis and Valuation

    Situation: A preclinical precision medicine biotech company, looking to leverage their genome editing platform technology, was seeking support in narrowing

     

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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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  • Business Planning and Launch

    Situation: An emerging concierge patient healthcare services company was nearing launch and requested that Kineticos support the final stages of

     

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  • Functional Process Improvement

    Situation: A leading global contract research organization dissatisfied with their lab’s scientific affairs function retained Kineticos to conduct an operational

     

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  • Objective vs. Subjective Evaluation

    Written by Abe Maingi, Senior Analyst, Kineticos With the NFL draft just being completed and the NBA draft forthcoming, I’ve

     

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  • On the Importance of Primary Market Research

    Written by Myung Soo Kim, PhD, Research Analyst, Kineticos Pharmaceutical companies are frequently challenged with determining the optimal clinical development

     

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  • Continued Companion Diagnostics Growth

    Written by Bill Finger, Executive Vice President & Managing Director, Kineticos Since I last touched on how popular the companion

     

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  • A Primer on Demand Generation

    Written by Kevin Hampton, VP of Marketing, Kineticos Heading up Marketing for a start-up professional services company presents a variety

     

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  • Shaping Elite Performance

    Written by Abe Maingi, Senior Analyst, Kineticos Prior to starting my professional career as an analyst at Kineticos, my primary

     

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  • Amazing Science, Engaging Leaders, and Improved Outcomes

    Written by Mark Osterman, Senior Vice President, Kineticos As many parents have experienced at one point or another, my children

     

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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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