At Blue Frog Scientific, we are experts in the environmental risk assessment (ERA) requirements for human and veterinary medicinal products in both the EU and UK. Our team provides specialist support to ensure compliance with regulatory frameworks governing the environmental impact of pharmaceuticals.
Human Medicinal Products Environmental Risk Assessment
We conduct comprehensive environmental risk assessments for human medicinal products, ensuring compliance with EU Directive 2001/83/EC and UK Human Medicines Regulations 2012 (SI 2012/1916). Our expertise supports the assessment of potential environmental risks associated with active pharmaceutical ingredients (APIs), enabling regulatory approval in line with EMA and MHRA expectations.
Veterinary Medicinal Products Environmental Risk Assessment
For veterinary pharmaceuticals, we provide tailored environmental risk assessment solutions in accordance with Regulation (EU) 2019/6 and the UK Veterinary Medicines Regulations 2013 (SI 2013/2033). We assist in evaluating the impact of veterinary medicines on soil, water, and non-target species, ensuring compliance with regulatory requirements set by the EMA and the UK Veterinary Medicines Directorate (VMD).
Blue Frog Scientific delivers the scientific and regulatory expertise needed to support successful pharmaceutical registrations in the EU and UK, ensuring environmental safety and compliance with evolving legislation.
