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SEM-EDS and Raman Spectroscopy to Accelerate Generic Drug Applications

This presentation examines SEM-EDS and Raman Spectroscopy as a means to accelerate generic drug applications.
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Understanding Global Regulatory Requirements for Nasal Drug Products

This presentation examines global regulatory requirements along with regulatory approaches for bioequivalence and an overview of FDA drug specific guidance.
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Adapting Pharmacopeial Testing for Pharmaceutical Equivalence Studies

This presentation examines regulatory approaches for bioequivalence and a comparison of compendial testing and pharmaceutical equivalence for Brazil.
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Inhalation & Nasal Device Overview

This presentation gives perspective to understanding the rationale for nasal and pulmonary drug delivery and provides guidance for differentiating between device attributes for inhalation and nasal platforms.
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Leveraging Old Drugs: A Critical Review of Delivery Systems and Life Cycle Management

Presented at RDD EUROPE 2015, this presentation takes a critical look at delivery systems and their life cycle management, including looking at the benefits and challenges.
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Qualifying Container Closure Systems for OINDP: Current & Future Regulatory Expectations

This presentation examines OINDP container closure system attributes and reviews the requirements of extractables and leachables.

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