Uncategorized

ANDA Stability – Q & A

The EMA has recently published a draft revision to Annex 15 (Qualification and Validation).  In addition, on February 27, 2014 they published the “Guideline on process validation for finished products – information and data to be provided in regulatory submissions

Bioavailability for NDAs

Mfg. Changes for APR

Tablet-Capsule Physical-Draft

Analytical Methods Validation-Draft