Preclinical
The experts at DataRevive are ready to provide invaluable insights and services as your small molecule discovery moves into preclinical studies, dose evaluation, and clinical trial design. We help you select the optimal regulatory pathway, including assessing designation options for expedited drug development. When the time comes to prepare and submit your IND application to the FDA, tap DataRevive’s industry-leading experience. From Pre-IND meetings to assembling the IND application, writing the IND dossier, designing the clinical studies, and, ultimately, submitting the IND application for FDA approval, our team provides hands-on guidance and oversight every step of the way.
Clinical Trials
As your small molecule begins to move into human testing at all scales through rigorous clinical trials, DataRevive offers experts who can perform clinical study execution for all phases, protocol writing, clinical site monitoring, pharmacovigilance, and the statistical analysis required to parse through clinical results. Once safety, proof of concept, and regulatory proof are all established, DataRevive’s team of former FDA professionals will guide you through the NDA process, providing services for NDA dossier writing, NDA assembly, FDA meeting preparation and representation, NDA submission, and marketing application submission.
Marketing and Safety Monitoring
Once approval is secured, DataRevive’s depth and breadth of expertise can help you move your small molecule drug through the final stage of the regulatory pathway on its journey to consumers. Our marketing and safety monitoring services include post-approval study support, long term pharmacovigilance, GMP audit support, and more to ensure you reach the market as efficiently and smoothly as possible.
