Environmental Risk Assessment Services

Environmental Risk Assessment (ERA) Services for Human and Animal Drug Products

Key Expert Services

Ensuring Regulatory Compliance and Environmental Risk Assessment (ERA) Protection with Zenovel

At Zenovel, we offer specialized Environmental Risk Assessment (ERA) services for both human and veterinary drug products. Our comprehensive approach evaluates the potential environmental impacts that may result from the use, storage, and disposal of pharmaceuticals, ensuring compliance with international regulatory frameworks while protecting ecosystems and public health.

ERA for Veterinary Medicinal Products

For veterinary pharmaceuticals, Zenovel conducts ERAs with a focus on the environmental release of active substances via excretion from treated animals, assessing potential impacts on non-target organisms and ecological systems.

Our ERA Service Portfolio

Zenovel offers end-to-end support across all stages of the ERA process:

  • Tier I and Tier II ERA Assessments for human and veterinary drugs
  • Preparation of ERA Waiver Justifications for generic product submissions
  • Regulatory Interactions with environmental competent authorities
  • Persistence, Bioaccumulation, and Toxicity (PBT) Screening
  • Preparation of Ecotoxicology Study Summaries in line with ECHA dossier formats

Commitment to Sustainable Compliance

The goal of Zenovel’s ERA services is to assess and reduce the risk of adverse environmental impacts—to human health, biodiversity, and ecosystems—while supporting the safe use, storage, and disposal of drug products. We ensure this information is clearly communicated in Summary of Product Characteristics (SmPC) documents and product labeling.

Reach out to us for any inquiries or support needs.

Blogs and news

Our Latest Article