Grants Management

The opportunity to conduct novel research lies in successful grant attainment, which typically is achieved through excellence in proposal writing. Our team of administrators, scientists, and medical writers excel at identifying, developing, and administering grants for innovative biomedical research programs. Our staff specializes in providing support for grant operations, including the execution of collaborative agreements, hiring and training experienced research staff, and facilitating acquisition contracts for specialized equipment and services. We also can assist with identifying funding opportunities through both federal agencies and private organizations, planning technical aspects of grant submissions ( including the study design), determining statistically-powered sample sizes, performing literature reviews, and defining the resources and equipment required to execute the proposed research. Our team can support the entire process from preparing submission documents, ensuring proposal compliance, providing detailed accounting for technical and budget requirements, and supplying the necessary supporting documentation, to full-service grant administration post-award. Our administrative support, coupled with technical expertise, can streamline the award process and facilitate the execution of innovative research projects and programs.

Biomedical research and pharmaceutical development are highly regulated to ensure safety and ethical compliance. While adherence to the large number, and ever-changing requirements, of these laws, statutes, and regulations may seem overwhelming to researchers, our regulatory affairs subject matter experts can streamline integration and compliance and assist with all aspects of regulatory submissions. Our team has experience with all aspects of regulatory affairs in the areas of pharmaceuticals, biologics, and medical devices in the U.S. and internationally. We understand that creating and implementing a sound regulatory strategy early in the development process is critical to ensuring that the correct regulatory pathway is selected and that all necessary pre-clinical safety and toxicity testing, shelf-life and stability studies, quality and design controls, manufacturing process validations, and clinical trials are planned and mapped out to meet regulatory requirements. Our regulatory affairs experts review every project and assist in developing the appropriate regulatory strategy for the drug or vaccine. Our expertise navigating these sometimes-complex regulatory processes ensures these important therapies successfully and efficiently transition to the healthcare system and, ultimately, the patients who need them.