Get the Facts: NDA-Enabling Studies
The development of an NDA submission plan can sometimes be unclear. Partnering with the right CRO early on can increase your chances of success and ensure you meet your milestones. With over 25 years of experience, Altasciences' specialists apply their knowledge in designing, conducting, analyzing, and reporting on trials for regulatory submissions, across the spectrum of therapeutic areas.
Our complimentary fact sheet guides you through the different study types and features of NDA-enabling clinical pharmacology studies, and how we can support you.
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Want to learn more about some of the requirements for each study? Explore these insightful resources:
- Proof-of-Concept in Special Populations
- Renal and Hepatic Impairment
- Drug-Drug Interaction
- Thorough QT
- Human Abuse Liability or Potential
- Cognitive Assessment Driving Simulation
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.