The development process is constantly evolving…
For over 30 years, Hurley Consulting Associates has specialized in Finding Solutions for its clients' regulatory and commercial development needs.
With our unique expertise to prepare global regulatory submission documents, we integrate CMC, nonclinical, and clinical, perform data analyses and develop regulatory strategies. We also design development programs and can provide the expertise for oversight of manufacturing, nonclinical programs, and clinical programs. We also conduct Phase I and Phase II clinical trials.
Our domestic and international consulting clients range from early developmental (pre-IND) to later stage potential products.
In addition to our traditional consulting services, our internal methodology has now been captured in RegCheck™ (www.myregcheck.com), a stand-alone tool used to perform the regulatory and scientific assessment that is the basis of GAP analysis. The RegCheck™ method has been proven to avoid costly late-stage rework and potential delays in bringing a product to market.
RegCheck™is a secure, cloud-based platform for driving drug development from pre-IND to NDA submission, providing the tools for regulatory and technical review of nonclinical and clinical documents which are intended for submission. It includes 106 checklists covering Modules 3, 4 and 5; over 4,600 report elements; and links to over 6,800 Regulatory Citations. Each of the 2,049 unique checklist elements is annotated and linked to 21 CFR and ICH, FDA, and OECD guidelines.
Stop by our booth #4035 for more information on how we can work with you to achieve your development and commercial objectives.