We help you to scale the heights!
Expert Services
New medicine development can feel like the high jump. How can you scale the heights required in science, the regulations, guidelines, understanding of patient needs, to name only a few areas?
The number of novel molecules that are taken through to approval each year has hovered at about 35 for years. Given the hundreds of thousands of molecules worked on each year, the rate of failure is clearly high. How can you and your team maximize the chances of success? Predictability is crucial.
The team you select predicts for success or failure. Speid & Associates are experts in new medicine development, including global and strategic regulatory affairs, the area that most often causes failure.
Only some of the expert services available are described on this page. If you do not see the service you need, email LSPEID@SNDTM.COM, start a chat, or call Dr. Speid at 001 858 531 6640.
Global and Strategic Regulatory Affairs
- Regulatory strategy services
- IND / CTA Application
- Clinical Trial Applications
- New Drug Applications
- Biological Applications
- Orphan drug regulatory affairs services
- Rare disease regulatory affairs
