Please select an area of interest below for more information.
Halloran Consulting works with our clients to ensure that the data generated during preclinical studies will be acceptable to the Food and Drug Administration or other regulatory agencies and supports the proposed clinical evaluation of the drug or biologic candidate. Preclinical studies often require the assistance of external contract laboratories and preclinical vendors and choosing the right facility and expertise is essential. Halloran assists clients in evaluating and selecting vendors and cost structures that ensure success in the first formal steps of the development process.
Halloran Consulting partners with our clients to ensure the regulatory pathway is clearly defined and executed, whether it be initiating contact with the Food and Drug Administration (FDA), as well as other non-US regulatory agencies, requesting and preparing for meetings with them or compiling investigational new drug documents and amendments. Our goal is to help our clients present the scientific and medical opportunities of the drug and biologic candidate in a straightforward manner while building a collaborative and collegial relationship with the FDA.
Halloran Consulting works closely with our clients to provide strategic oversight, regulatory consulting and clinical operations services. We help select vendors, such as clinical research organizations, and evaluate and implement the right clinical trial technology, such as electronic data capture or clinical trial management systems. We work with our clients based on their long-term strategy to provide services that enable companies to remain virtual or help them build the internal infrastructure needed to develop a fully integrated clinical team.
As the clinical program becomes larger, Halloran Consulting helps our clients ensure that the right organizational structure is in place so that teams are operating effectively and efficiently. In addition, we work to design and implement the right quality management systems to that companies maintain compliance with government agencies as they move through the clinical development and regulatory approval processes.
Halloran Consulting works with our clients to help them optimize the management of their global Phase 3 trials, often involving multiple contract research organizations, vendors and international sites. Conducting an early Phase 3 gap analysis has become a proactive method for mid-stage correction of operational or data quality issues critical for a successful New Drug Application filing. Our goal is to help companies meet the stringent quality standards now required in pre-approval regulatory inspections, as well as adhering to timelines and remaining on budget while planning for their filings.
Halloran Consulting works with clients throughout the approval process (New Drug Application, Biologic License Application or Marketing Authorization Application) including managing teams to write and compile the registration dossier, auditing preclinical, clinical and manufacturing sites, conducting reviews of internal regulatory processes and quality systems as well as directly interfacing with FDA or other regulatory agencies regarding the application. We optimize and streamline the regulatory process to ensure as rapid a regulatory review as possible.
Halloran Consulting will continue to work with clients after product approval to assess and improve organizational efficiency and quality compliance. As organizations grow to develop into fully integrated sponsor companies, Halloran's team will assist with the strategic design and implementation of change management initiatives.