Human Pharmaceuticals
Full Environmental Risk Assessment for Your Product
Brixham Environmental Laboratory offers a comprehensive range of management and laboratory services to help you meet the environmental safety requirements of a new drug development.
As our client you will experience excellent services backed by an outstanding long-term track record for quality, personal approach and attention to detail.
Pharmaceutical products can only be sold after a marketing authorisation application (MAA) has been submitted and granted by appropriate authorities. For Europe, the content of the MAA is basically defined in the Directive 2001/83/EEC, and in the notice to applicants.
The first and probably the most important part of an MAA for a new active substance is the dossier summary, which contains the expert reports. These summarize the results of the various experimental studies, to enable the authorities to judge the risks and benefits of a new active substance.
We can help with the preparation of the environmental data for these dossiers.
In order to assess the potential impact of pharmaceuticals in the environment, a realistic estimation of their probable environmental concentrations is required. This would include an assessment of their potential to degrade and partition between environmental compartments. A full range of test procedures is available at Brixham Environmental Laboratory to deliver a full risk assessment, helping you to achieve your product registration goals, rapidly and cost effectively.
New EMEA Guidance
Pharmaceutical companies will be required to have a far greater understanding of the environmental impact of their products, and Brixham Environmental Laboratory , a world leader in environmental risk assessment, has the skills, resources and expertise in place to help you deal with the demands of these requirements.
