RegAffairs

Regulatory is serious business. Based on an average review timetable of one year for a new product, it takes experts with the knowledge, leadership, and proven track record to expedite this process. No one takes it more seriously–or is better prepared for it–than aktaPD®.

We can:

  • Devise a strategy for presenting existing nonclinical and clinical data
  • Determine the extent of literature review needed
  • Ascertain whether a pre-IND meeting is desirable
  • Advise when and how to submit your IND
  • Troubleshoot key obstacles prior to FDA review process
  • Participate in pre-IND and pre-NDA meetings through and beyond to label negotiations
  • Anticipate and file for any applicable accelerated and/or orphan programs

Along with regulatory approval, our capabilities include marketing approval submission activities: developing and maintaining detailed time lines, determining how best to pool and present data from the completed clinical trials, and coordinating the efforts of personnel from multiple functional areas (clinical, nonclinical, CMC, statistics). And if an assessment of in-licensing M&A opportunities or internal development options is required, we provide invaluable assistance by critically reviewing nonclinical, clinical, medical, regulatory, and/or commercial documentation to assure that it is scientifically sound, acceptable, and reimbursable.

Ready for a seasoned team to advocate for you and help turn your good ideas into marketable products? Contact us.