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.
Small life science companies often need to ‘do more with less.’ Leaders of these companies must seek ways to trim costs without sacrificing quality and speed. As you build your development team, you may be tempted to forgo hiring a Program Manager, but that decision may create less-than-desirable results. Leaders of life science companies, especially […]
Read our latest Case StudyTurning Drug Development Chaos into Order for an NDA Situation The average approval time often takes 10-15 years from Phase 1 to approval. The cost of drug development for sponsors ranges from $314 million to $2.8 billion. The milestone of submitting a New Drug Application (NDA) for approval by the U.S. […]
Providing Clinical Leadership for Early-Stage IO Biotechs from a Leader Who Built Her Own Clinical Support Group
This content was originally published in Women Leadership in Immuno-Oncology Issue 2023. Click here to read the original article. What does Halloran Consulting do in immuno-oncology? Our expertise is strategic program leadership, clinical development planning, regulatory affairs, and regulatory operations to early-and late-stage biotech and pharma companies with immuno-oncology assets. In some cases, we act […]