Skip to Content


Our Halloran experts with deep expertise in science and advanced knowledge of the development and commercialization lifecycle, lead our clients thru their most challenging business goals to achieve their greatest chance of success. Whether we are leading new company formation with a fully integrated development team at the ready, enabling investments with robust diligence or market assessments, or providing accelerated, durable development strategies for enhanced company value creation, we are your development partner.


Combining our scientific expertise, business and organizational focus, and advanced knowledge of development and commercialization, we lead our clients thru new company formation at any stage. We provide strategic program leadership to integrate and lead the most complex development strategies and cross-functional team activities, deploy an experienced integrated team at the ready serving as an extension of your team, and guide accelerated development and organizational strategies enhancing company value creation

Beyond evaluation of intellectual property, scientific soundness, and the commercial market for a life science asset, key elements of a thorough Due Diligence process include 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 helps our clients gain competitive advantage and stay ahead of the industry by strengthening their internal competitive intelligence. We partner with our clients to gather vital information on the external environment and key stakeholders in their specialized focus area. Our research covers insights on patient-centric recruitment strategies and trial design, trending clinical strategies as well as clinical and regulatory precedence, accessible regulatory pathways and special designations, decentralized and data-driven technologies, and macroeconomic data affecting the industry as a whole. We provide this research in the form of meaningful and actionable insights and recommendations that our clients can use to fuel decision making.

We help many early stage clients identify which development pathway is right for their business goals. Halloran helps to identify which assets and indications to prioritize and de-prioritize based on the client’s desired timeline, budget, early preclinical data, and clinical, regulatory, and commercial attributes. As part of this work, a Risk-Benefit Analysis for developing a drug or device in the indications under consideration can be provided as a guide to help mitigate potential pain points during the development.

When it comes to fundraising, being able to clearly communicate a company’s unique positioning and competitive advantage is key. Halloran has helped many early stage clients achieve their next round of funding. We strategize fundraising pitches with our clients and supplement their investor decks with slide deliverables that cover our assessment of the market opportunity, a value creation roadmap, an asset and indication prioritization plan, and a custom regulatory and clinical strategy. The slide deliverables will come complete with the required timelines and budget for each recommended step along the way, a critical step in demonstrating value to potential investors.

An Integrated Development Plan is a tool to streamline development strategy, highlight efficient development pathways, and to optimize the speed and efficiency of asset development. Halloran uses an integrated, cross functional lens to provide benchmarking, assumptions, risk analysis, and resource planning with coordinated timelines and budgets for our client’s programs. This plan is broken out by key activities and functional areas across clinical development, regulatory, chemistry manufacturing and controls (CMC), and non-clinical development. Throughout the creation of the Integrated Development Plan, we become our clients’ trusted partner to accelerate progress and are fully prepared to lead the implementation of the plan, if desired.

Our experts act as development program leaders and program managers to define the strategy within our clients’ cross-functional teams and lead the development program forward through execution. Halloran’s interim program leaders offer our clients a competitive advantage through integrated insights and learnings from the development of similar types of products in the industry.

Our experts act as the leaders on our client’s development team to set strategy, advise, and lead executive-level roles including COO, CDO or other R&D functional heads across their organization. Halloran’s interim leaders offers our clients a competitive advantage through insights and learnings from the development of similar products in the industry.

Whether we are functioning as a core executive team member or acting as an extension of our client’s existing team as an Advisory Board member, we are their trusted partner to provide actionable, practical advice to move the product and company forward.

Inc. 500
sage intacct

I am honored to be working with our researchers and team leaders delivering guidance, vision, and value for our partners.

Carolina Ahrendt

Associate Principal Consultant, Program Leader


Together, We Can Get You to Your Ultimate Business Goals

Our experts can craft innovative development strategies around your study design concepts, timelines, and budget to achieve your goals.


  • Site startup for a clinical trial will always be a challenge. Why? While driving the study forward and gathering cross-functional expertise to operationalize a successful study, site startup is comprised of many unexpected hurdles that may get in the way of meeting clinical development milestones.  Site activation is not an easy or rapid process. Based […]

  • As a panelist at CORE (Clinical Operations Retreat for Executives) East, hosted in Chatham, Massachusetts, I had the privilege of participating in a lively discussion on the theme of driving change with a patient-centric focus. This session brought together a remarkable group of experts advocating for early patient engagement throughout the entire clinical development process, […]

  • Planning, assembling, and editing a Chemistry, Manufacturing, and Controls (CMC) dossier is a critical part of every clinical trial application and marketing authorization submission. Every CMC dossier requires the compilation of copious amounts of data from various departments (i.e., Research and Development, Manufacturing, and Quality). Regulatory and technical authors must then summarize these data according […]