Gloved hands holding a beaker

Pharmaceuticals

We have extensive experience in assessing the potential environmental risk posed by pharmaceuticals.

Environmental Risk Assessment

Blue frog have been preparing environmental risk assessments for over a decade. In that time we have seen the Authorities expectations for content and scientific rigour increase significantly and we have reacted accordingly, ensuring that our assessments are of the highest quality. We work with our Clients to define the scope of the assessment, exploring possible refinements before commissioning studies. The way we work with you is defined by your needs. For some Clients this means taking overall management of the project, for others taking responsibility of individual parts. 

Our scientific team ensure the laboratory tests are conducted to meet the needs of the assessment, most of our staff have previously held senior scientific roles in laboratories.

  • Project management
  • Commissioning and monitoring studies
  • Review of study plans and reports
  • Troubleshooting studies
  • Preparation of ERA and Module 6.1
  • FDA CDER assessments
  • Post submission support and defence

Additional services include:

  • Pre-testing QSAR evaluation of fate and effects to aid  budgetary forecasts, program development and targeted testing strategy
  • Literature search and reliability assessment, data mining of extensive databases for gathering relevant data, identification of structurally related molecules
  • CRO liaison for generation of quotes and schedules
  • GLP Study Monitoring
  • Project management with regular updates set at client specified intervals
  • Pre- and post- submission regulatory support

 

Pharmaceuticals -
OUR APPROACH

"We offer friendly, customer focused consulting services, making your regulatory obligations cost-effective."

Tom Hargreaves
Director

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07 Mar 2017

Blue Frog Exhibiting at SOT 56th Annual Meeting and ToxExpo

We are proud to be exhibiting at SOT for the first time!...

Why Blue Frog