Gap Analyses and Due Diligence, Licensing Support Activities
Impact conducts detailed cross-functional reviews to assess the acceptability of data packages to support successful IND or NDA submissions. Based on these reviews, we provide remediation plans that identify any “gaps,” as well as what’s required to fill them. Likewise, if your need is to assess in-licensing opportunities, our experienced staff can provide licensing support by reviewing nonclinical, clinical, medical, and/or regulatory documentation to assure that they are scientifically sound and acceptable. Through these reviews, we help clients determine probability of regulatory success, as well as assign value to potential acquisition targets.