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February 2023

FDA Submissions Using eCTD Formatting: Structural Overview & Common Hurdles

Making an eCTD-compliant submission to the FDA requires complex coordination of stakeholders and a detailed culmination of information. Translating years of product information must be done in a way that provides the necessary information to FDA and frame it into the correct formatting for review; a task often requiring seasoned support. Avoid technical issues preventing or

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Get Ready for A Stack Test – The Planning Phase

Stack testing, also called performance testing or emissions performance testing, is a procedure for sampling various types of emission sources at a facility. It is a critical tool to determine compliance with U.S. Clean Air Act regulations, state regulations, and air permits. It also provides real-world data for emission inventories and air quality modeling. Stack

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