THE DOSSIER SUPPORT YOU NEED TO GET YOUR NDA, MAA, BLA, OR PMA DONE. YOU CAN COUNT ON US TO MEET YOUR REGULATORY SUBMISSION DEADLINES.

Ready Set Submit

THE DOSSIER SUPPORT YOU NEED TO GET YOUR NDA, MAA, BLA, OR PMA DONE. YOU CAN COUNT ON US TO MEET YOUR REGULATORY SUBMISSION DEADLINES.

In the past 5 years:

  • 12+ Full NDA submissions
  • 60+ CDISC conversions
  • 20+ ISS/ISE preps
  • 9 FDA/EMA representations

The dossier submission always has a tight timeline and much riding on it – hitting the defined timeline is the ultimate measure of clinical drug development success. Preparing the NDA, BLA, MAA, or PMA always takes longer than expected, and should be started earlier than most drug developers anticipate. Sponsors often discover this process takes more people with programming, analysis, and writing expertise than available within their company or with their current trial partner. Further, additional regulatory guidance may be necessary since teams may not have the most up-to-date knowledge of the changes in the regulatory landscape or may not be familiar with the regulatory agency with which they are filing.

When you need help, call Synteract. We have extensive experience in managing full NDA submissions including regulatory services, CDISC conversions, ISS/ISE preparations, and representation of sponsors at FDA and EMA meetings. All of this is in addition to countless occasions when we have provided assistance with planning stages, pre-NDA meetings, statistical foundation, Advisory Committee meetings and other aspects. Our experience helps to improve your submissions.

Introducing: Ready Set Submit

Our Ready Set Submit bundled service offering will help you bring it all together to complete your submission on time. We can work with you across all these needs, or just lend support on individual aspects along the preparation path. We provide you a multi-disciplinary and cross-functional team that works together seamlessly, led by a submission project manager with experience unique to leading the dossier preparation and submission process. The sponsor benefits from working through one experienced point of contact yet accessing the expertise of many.

Ready Set Submit services include:

  • Integrated analysis plans
  • Data pooling
  • Dictionary coding and recoding for consistency
  • ISS and ISE creation
  • NDA, BLA, MAA writing, compilation and submission
  • eCTD production, including preparation, bookmarking and hyperlinking as well as submission through electronic gateways
  • Statistical consultation and representation
  • Strategic guidance and support for FDA/EMA meetings

Even when your trials work perfectly, taking new products successfully through submission and approval can be a challenging and lengthy process. Contact us early to get the support you need from our highly responsive and experienced regulatory affairs, biostatistics, medical writing, medical coding, and programming experts.

Call us to see how Synteract’s Ready Set Submit services can help you!

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