Are you NDA-Submission Ready?

 
Altasciences Clinical Research
Are you NDA-Submission Ready?
Timeline

We can design and conduct your clinical pharmacology studies starting with first-in-human, and continue to the complete package of NDA-enabling studies. We can help you prepare for the end of your Phase II meeting by designing the clinical pharmacology studies you will need to review with the regulatory agencies.

Each study type has its own set of requirements, and its own design.

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SAD/MAD with POC

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Drug-Drug Interaction

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Pharmacokinetics in special populations

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Hepatic or Renal Impaired

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Cognitive Assessment

 

and many more...

Find out more and get a head start!

 
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