ClinOps

Getting a new product to market is a multi-year process that requires numerous studies in a tightly-regulated and resource-constrained environment. Add to that the pressure of having to substantially increase the number of trial participants along with the number and frequency of safety and diagnostic testing. Plus, there’s the intense scrutiny of product safety and stringent regulatory controls around the world. Experienced partners can be crucial to your success as you traverse the complex and challenging course of biopharmaceutical development.

aktaPD® is your experienced partner. We work closely with you to prepare a detailed pharmaceutical product development plan – from target product profile to Phase 0/first-in-human trials (FIH) to an NDA or BLA filing – that covers all technical aspects (clinical, nonclinical, regulatory, and CMC) and includes detailed cost estimates and time lines. In an integrated and collaborative manner, our experts work with you to design the optimal program that meets the current regulatory requirements.

 

Ready to improve your clinical studies and optimize time, money, and results. Contact us.