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OAI: Ostrove Associates, Inc. OAI: Ostrove Associates, Inc.

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ANDA Stability – Q & A

May 14, 2014April 13, 2018 Steve OstroveUncategorized

ANDA Stability – Q & A

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New EMA Documents

March 30, 2014April 13, 2018 Steve OstroveUncategorized

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

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Bioavailability for NDAs

March 30, 2014April 13, 2018 Steve OstroveUncategorized

Bioavailability for NDAs

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Manufacturing Changes to be Reported in the Annual Report

March 6, 2014April 13, 2018 Steve OstroveUncategorized

Mfg. Changes for APR

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FDA Draft Guidance – Generic Tablets & Capsuls

February 28, 2014April 13, 2018 Steve OstroveUncategorized

Tablet-Capsule Physical-Draft

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New FDA Guidance Document – Laboratories

February 28, 2014April 13, 2018 Steve OstroveUncategorized

Analytical Methods Validation-Draft

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Recent Posts

  • ANDA Stability – Q & A
  • New EMA Documents
  • Bioavailability for NDAs
  • Manufacturing Changes to be Reported in the Annual Report
  • FDA Draft Guidance – Generic Tablets & Capsuls
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