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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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Which PFAS will be regulated next?

Lately, we’ve all been watching and waiting for the EPA to publish its proposed MCLs (Maximum Contaminate Levels) for PFOA and PFOS and to designate these two compounds as hazardous substances under CERCLA (the Comprehensive Environmental Response, Compensation and Liability Act). These two actions will have a huge impact on everything from Public Water Systems,

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