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The Camargo Blog

Get insight and information from our team of experts to improve your pharmaceutical development and commercialization strategy.


September 12th, 2018

Looking for Clarification on Reporting Post-Approval Changes to a Drug Substance to the FDA? You are in Luck.

May 16th, 2018

Getting Liposome Drug Products Approved: They Are Non-Biological Complex Drugs

December 14th, 2017

Chemistry, Manufacturing, and Controls Requirements: Bridging and 505(b)(2)

August 17th, 2017

Stability Requirements in the 505(b)(2) Space: Why, What, When, How

July 19th, 2017

What Went Wrong? Make Sure Your Bridge Stays Intact, CMC and Dissolution

January 5th, 2017

Improvements and Updates to the FDA Inactive Ingredient Database

July 7th, 2016

505(b)(2) CMC Basics: Aligning Chemistry, Manufacturing, and Controls with Clinical Trials

March 7th, 2016

How Much Is a First Cycle Review ANDA Approval Worth to You?

July 21st, 2015

Use of Extrusion-Enabled Pharmaceutical Processes in Drug Development via a Streamlined Regulatory Pathway

December 10th, 2014

Manufacturing Support for “Breakthrough Therapy—Designation for Solid Oral Dosage Forms

January 19th, 2014

2013 505(b)(2) NDA Approvals

September 25th, 2012

New Generic Stability Requirements

August 8th, 2012

K-V Pharma Bankrupt—Claims FDA Doesn’t Back Makena

April 15th, 2012

Drug Development Planned Like the Titanic

February 7th, 2011

Mitosol—An Orphan & 505(b)(2) without clinical studies

February 1st, 2011

Injectables: 505j or 505(b)(2)?

October 5th, 2010

Why have a Quality Overall Summary for the Quality Module?

June 10th, 2010

Labeling for Abuse-Deterrent Drugs

May 14th, 2010

Target Product Profile

April 30th, 2010

CMC Issues Again

April 23rd, 2010

Manufacturing Problems for Intravenous Emulsions

March 2nd, 2010

Do Not Neglect Your Third-Party Drug Substance Manufacturer

February 11th, 2010

Can and Should ANDA Labeling Differ from the RLD?

January 7th, 2010

Analytical Requirements for Oral Solutions

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Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.


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