What Is Environmental Risk Assessment (ERA) Phase II Tier B?
Environmental Risk Assessment (ERA) Phase II Tier B is a more detailed environmental investigation undertaken when the findings from an earlier assessment indicate that further evaluation is required.
What Is Environmental Risk Assessment (ERA) Phase II Tier A?
Environmental Risk Assessment (ERA) Phase II Tier A is the next stage in evaluating the environmental situation after a Phase I assessment has confirmed that there are environmental hazards that require further evaluation.
What Is Environmental Risk Assessment (ERA) Phase I?
The Environmental Risk Assessment (ERA) Phase I is regarded as the earliest environmental due diligence procedure. Its purpose is the analysis of environmental issues related to property, a facility, or a project.
FDA Updates Forms FDA 1571 and FDA 356h: Key Changes
FDA has released updated versions of Form FDA 1571 (05/2026) and Form FDA 356h (05/2026) to support PDUFA VII requirements and improve data quality and usability.
What Is Regulatory Submission Planning?
Regulatory Submission Planning is a process that allows the pharmaceutical, biotechnology, and medical devices sector to better organize and manage all the activities related to regulatory submissions.