Halloran acts as our clients’ executive regulatory representative at health authority meetings and coaches our clients through their regulatory communication strategy. We proactively assess the optimal time our clients need to positively engage health authorities, identify the critical questions and plans to obtain concurrence to move forward, and develop meeting requests and strategically positioned briefing books. We lead teams through practice sessions and pre-meeting coaching to prepare for communication with health authorities. If desired, we can lead the actual interaction with health authorities on our clients’ behalf. Halloran has deep experience in INTERACT, PreIND, End of Phase, PreNDA/PreBLA meetings with the US FDA and other comparable meetings with worldwide health authorities.

We prepare and submit applications for special designations such as orphan, fast track, breakthrough, and rare pediatric disease vouchers to help drive clinical programs forward. Appropriate designations shave invaluable time and money off of development programs.

Halloran’s regulatory team can see programs through to marketing applications (NDAs, BLAs, PMAs, 510(k)s) and beyond. We advise our clients on critical late stage development programs to ensure success. We can act as advisors, authors, and everything in between.

Once we have an agreed-upon regulatory strategy, Halloran does not stop there.  We work with our clients’ team members to implement the strategy. We advise our clients on the development of content for the clinical trial documentation (INDs/IDEs, CTAs, etc.), or alternatively, we can stand in as the authoring team to develop the content for clients. We make sure the investigational application reflects the right approach for each client at each stage of development.

Our experts work together with the scientific experts on our client’s team to incorporate insights and learnings from the development of similar types of products to set strategy, advise, and lead a custom winning regulatory strategy. Halloran performs gap assessments and readiness assessments for the existing program, develops integrated development plans and regulatory roadmaps, and designs and implements special designation strategies, as applicable. We will develop and prioritize potential regulatory approaches based on our client’s development goals, corporate milestones, budget, tolerance for risk, early data, and our breadth of regulatory intelligence from our direct experience in the industry and our knowledge of the competitive landscape.

Our Regulatory Chemistry Manufacturing and Controls (CMC) team are experts in product types ranging from small molecules to cell and gene therapies. We also have experience with proteins, monoclonal antibodies, oligonucleotides, antibody drug conjugates, live biotherapeutics, and more than minimally manipulated products.

Our experts work with our clients to develop drug substance and drug product strategies that are fit for their stage of development, whether that be an early IND or a marketing application. We advise on critical product development quality issues during development. Additionally, we have full authoring capabilities for Module 3 / Quality sections of regulatory submissions for all product types.

Our regulatory operations team partners with our clients to format, publish and submit regulatory documents on their behalf. We will attentively project manage all regulatory communications with health authorities and maintain all regulatory dossiers (IDEs/INDs, CTAs, 510(k)s, PMAs/NDAs, BLAs, etc.) with amendments, supplements, safety reporting, and annual reports.  We stay ahead of the latest technology to support compliant submissions and promote accelerating development through technology-enabled regulatory strategies. 

Our regulatory experts act as the regulatory leaders on our clients’ teams to set strategy, advise, and lead regulatory functions across their companies. Halloran’s interim leaders and regulatory experts offer our clients a competitive advantage through their insights and learnings from working with similar types of products in the industry.

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.