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Strategies for IND Filing Success: Chemistry, Manufacturing and Controls

Featuring RCA’s Dr. Sharon Ayd, this PharmTech webcast is designed to help guide pharma companies through the steps required to prepare the chemistry and manufacturing process information expected by FDA in an IND application.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Strategies for IND Filing Success: Chemistry, Manufacturing and Controls

Strategies for IND Filing Success: Chemistry, Manufacturing and Controls

Featuring Regulatory Compliance Associates® Inc.’s Dr. Sharon Ayd, this PharmTech webcast is designed to help guide pharma companies through the steps required to prepare the chemistry and manufacturing process information expected by FDA in an IND application. The slides address the application process and communications with FDA; identify required information about the quality, purity, strength, preparation, and stability of the drug substance and drug product; and explain the crucial analytical methods and validation processes needed for a successful filing.

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