Skip to Content

Biopharma Due Diligence

How we help with Biopharma Due Diligence

When faced with mounting pressures, external headwinds, and market uncertainty, having the best information to provide your company with critical information needed for employees and prospective investors. There is high intensity and pressure in the world of biopharmaceuticals to outperform competitors and get to market quickly.

Beyond the evaluation of intellectual property, scientific soundness, and the commercial market for a life science asset, key elements of a thorough due diligence process include the assessment of medical need and feasibility of the proposed development strategy including the regulatory and clinical aspects. We help fill the gaps in these critical areas with a due diligence assessment led by drug development experts with extensive regulatory, clinical, and quality experience. Our assessment yields greater understanding of the market opportunity in the context of the development landscape and helps our clients arrive at vital go-no-go decisions.

Halloran will engage with your company leadership, conducting a thorough review of its regulatory risks, requirements, and future challenges they may face. Halloran’s due diligence assessment is spearheaded by a group of experts with extensive regulatory, clinical, and quality experience. We can assess the operational complications to understand the market landscape. Additionally, we can provide a detailed report on key market observations, expected challenges, and recommendations to the company to guide its transaction decision-making process.


  • This comprehensive webinar offers an insightful exploration into the intricate landscape of New Drug Applications (NDAs) and Biologics License Applications (BLAs), elucidating the pivotal regulatory procedures imperative for pharmaceutical companies seeking approval for novel drugs and biologics. Its primary objective is to equip participants with the requisite knowledge and resources essential for navigating the intricate […]

  • The U.S. Food and Drug Administration’s (FDA) draft guidance, Master Protocols for Drug and Biological Product Development, released on December 21, 2023, provides expanded recommendations on the design and analysis of trials conducted under a master protocol. A master protocol is a protocol designed with multiple substudies, which may have different objectives and involve coordinated […]

  • The journey from research to development is a critical milestone for any biotech startup. This transition signifies the company’s progression from proving a drug’s potential efficacy to preparing for clinical trials, a pivotal step that underscores the startup’s early success. For many biotech or pharma leaders, especially those experiencing this shift for the first time, […]