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US NEW DRUG APPLICATIONS

Donawa Lifescience Consulting (DLC) understands the requirements for new drug applications in the US, and can assist in identifying the most appropriate requirements for your product, and then help with development of the necessary submission documentation.

We can assist with:

• New drug applications (NDA)
• Abbreviated new drug applications (ANDA) for generic products
• Biologic license applications (BLA)
• Orphan drug product applications (for rare diseases and disorders)
• e-CTD (common technical document) submissions

Feel free to contact us to see how we may be able to assist you.