ANDA Stability – Q & A
ANDA Stability – Q & A
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