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Quality Assurance, Control & CMC Accelerated review, approval, and access procedures that more efficiently address unmet patient needs have challenging consequences for the regulatory, technical, and quality requirements of drug development. This complexity increases the need for clearly communicating harmonized regulatory, technical, and quality standards. DIA provides a thorough understanding of requirements and strategies needed to support problem-solving as well as continuous improvements and innovation in biopharmaceutical manufacturing.

Common Deficiencies Found in the Active Pharmaceutical Ingredient (API) Section of Non-sterile Generic Products Submitted for Registration by SAHPRA


This research study aims to determine the qualitative and quantitative common deficiencies included in the API section of dossiers submitted to SAHPRA. The study was conducted retrospectively over a 7-year period (2011–2017) for non-sterile generic products that were finalised by the Pharmaceutical and Analytical pre-registration Unit.

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Submit an Abstract

DIA Abstract

Submit an abstract for an existing or future event on any topic that advances the pharmaceutical, biotechnology, medical device, and related fields.

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Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process Online Course

Register for this On-demand Training Course which will demonstrate CMC sections of regulatory submissions, the FDA inspection process, and how to avoid or minimize 483s (noncompliance) using real-life scenarios.

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Pharmacovigilance Quality Management System Online Course

This beginner to intermediate level hands-on virtual live training course describes contemporary principles, practical approaches, and regulatory expectations for the Pharmacovigilance Quality Management System.

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