Regulatory Consulting Support for Human Pharmaceuticals
Human drugs and biologics used in the U.S. are potentially subject to Food and Drug Administration (FDA) environmental assessment requirements. Registrants must prepare an Environmental Assessment (EA) or, if applicable, submit a categorical exclusion for their product. If required, the FDA-EA would include tests for physical/chemical characterization, biodegradation properties, microbial inhibition, environmental fate, and environmental effects. CSI can coordinate study placement and monitoring for these tests.
The approval of new human pharmaceutical products in the European Union requires assessment of potential environmental risks (ERA). Human drugs are regulated under Directive 2001/83/EC by the European Medicines Agency (EMEA). CSI-Europe can provide data evaluation and regulatory support to meet the two-phased assessment program required in the EU, including environmental fate and effects evaluation, exposure modeling, calculation of predicted environmental concentrations (PECs), and coordination of necessary higher-tier studies. We can also provide advice on the impact that legislative amendments may have on the continued authorization of your product line.
The regulatory arenas and the regulated industries we serve continue to change. As a company, CSI’s strength has come not only from being able to adapt to industry trends, but by anticipating and applying new regulatory and scientific strategies to add value to client product development and registration pathways. Keeping pace in our consultancy has required us to stay current on regulatory drivers and scientific approaches to deliver our best for each individual client and project. We extend this dedication to you.
If you would like further information about CSI’s services in the Human Pharmaceuticals sector, please Contact Us.