A faster, better way to market
Aptuit INDiGO® accelerates early drug candidates into the clinic by reducing time from nomination to regulatory submission in 52 weeks, and under circumstances, even less. We achieve accelerated development by tightly integrating traditional drug silos into a single project managed under one roof.
The program has been proven to reduce time and cost while achieving a quality data package for CTA/IND level regulatory filings.
Aptuit INDiGO® projects are managed by our most experienced, dedicated project managers and leading world-class drug development professionals implementing tailored development strategies designed specifically for the molecule, therapeutic area and strategic needs. The project plan is designed to integrate development areas: API Manufacture, Formulation Development, Clinical Supply, Safety Assessment, DMPK, Bioanalysis Studies and Regulatory Submission Documents Preparation.
Key features of Aptuit INDiGO® are:
- Each INDiGO® program is custom-designed for each molecule, taking into account all development factors including the type of molecule, dosage form and therapeutic area. Solutions are available for all therapeutic areas, small and large molecules, drug product changes post-FIM & IP extension opportunities.
- The project will be managed by Aptuit in collaboration with you according to an agreed-upon project plan, timeline and budget with agreed decision points identified throughout the course of the project.
Aptuit INDiGO® offers the following benefits:
- Time and cost savings
- Timelines and costs are well defined for the agreed development program, mitigating unexpected obstacles
- Integration and Project Management
- Seamless and efficient development with real-time adjustments to plan as required
- Integration of know-how and data across disciplines to maximize quality of the data package
- Experienced, dedicated Project Managers who are committed to delivering your project on time, in full and within budget
- Highly skilled experts in all disciplines with a track record of successful integrated development and INDiGO® packages
- Technologies and quality
- State-of-the-art laboratories, cutting-edge technologies and quality levels
- Customized communication strategy and real time provision of data with interpretation