Environmental Assessments: Don't Let Your Environmental Package Be a Regulatory Sticking Point

Seamless E/A Solutions from the Drug Development Experts at ABC

A quality Environmental Assessment (EA) package is a critical component of many new drug product submissions. Not having the right data—or not starting EA investigations soon enough—is an often-underestimated development risk. In fact, these common missteps can lead to lengthy environmental fate or ecotoxicity studies that will delay a drug's approval by up to two years. ABC helps develop drugs and evaluates their environmental impacts. Click here for more.

Cytotoxic Drug Development: Choose Your Partner Well

Choose Your Partner Well - Ask ABC

Although regulatory requirements are fundamentally the same for all investigational drugs, working with cytotoxic materials presents unique challenges. Heightened safety procedures and encumbering personal protective equipment can be a drag on timelines—or worse, lead to procedural or analytical errors that compromise data integrity. It's critical to choose a CRO with cytotoxic expertise, yet the field of competent outsourcing partners is small.

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