Streamline your drug development and registration process with AI-powered analysis of NDA, ANDA, IND submissions, and international regulatory requirements.
The primary vehicle for drug sponsors to formally request FDA approval to market a new pharmaceutical product. Requires comprehensive safety and efficacy data.
Pathway for generic drug approval. Requires demonstration of bioequivalence to an approved reference listed drug rather than independent efficacy data.
Application required before initiating clinical trials in the United States. Allows interstate shipment of an investigational drug for clinical investigation.
European Medicines Agency approval pathway for pharmaceuticals marketed in EU member states. Centralized procedure required for certain drug categories.
International Council for Harmonisation guidelines providing unified standards for pharmaceutical development, registration, and post-approval activities.
Good Manufacturing Practice requirements ensuring pharmaceutical products are consistently produced and controlled according to quality standards.
Comprehensive review of Common Technical Document modules against regulatory expectations and submission requirements.
AI analysis of clinical study reports for completeness, consistency, and alignment with regulatory guidance.
Evaluation of chemistry, manufacturing, and controls documentation against FDA and EMA requirements.
Review of proposed labeling against regulatory requirements and approved labeling standards.
IND-enabling studies and regulatory strategy
First-in-human safety and dosing
Efficacy trials and pivotal studies
NDA/ANDA/MAA preparation and review
Upload your regulatory documentation and receive comprehensive gap analysis. Identify issues early to avoid costly delays in your drug approval timeline.