Drug Development Strategy
Viglya helps clients develop regulatory strategies that focus on discovering and rapidly building scientific evidence to support the safety and efficacy of compounds. We assist in identifying and addressing critical path issues that could delay development timelines, and we help define the hurdles to registration. We provide strategic guidance in marketing authorization applications (MAAs), clinical (efficacy and safety) summaries, overviews, and labeling development.
Viglya also assists with legal representation activities in Europe and provides full United States (U.S.) Agent services, including U.S. Investigational New Drug (IND) submission, negotiation, and maintenance.