Blue Frog Scientific has a wealth of experience in conducting comprehensive Environmental Risk Assessments (ERA) for pharmaceutical products. Our approach has evolved with regulatory expectations – ensuring that each risk assessment is delivered to the highest standards of scientific rigour to help efficiently achieve regulatory compliance.
Comprehensive ERA Development
Initial Scoping & Refinement
We collaborate with clients to define the scope of the ERA, considering all regulatory requirements, possible waivers and potential study refinements before initiating any tests.
Project Management
Depending on your needs, our involvement can range from managing the entire project to overseeing specific segments. Our flexible approach is designed to integrate seamlessly with your internal processes and capabilities.
Study Design & Oversight
Our scientific team, comprising professionals with extensive leadership backgrounds, ensures that all tests are appropriately designed and conducted to meet the specific needs of the ERA.
Study Execution & Oversight
Commissioning & Monitoring Studies
We manage all aspects of study execution, from commissioning through to final reporting, including real-time troubleshooting and quality control.
Review & Analysis
Our experts rigorously review study plans and reports to ensure compliance with both scientific and regulatory standards.
GLP Study Monitoring
We oversee studies ensuring they adhere to Good Laboratory Practice (GLP) regulations, ensuring data integrity and regulatory acceptance.
Regulatory Documentation & Support
ERA & Module 1.6 Preparation
We prepare detailed Phase I and/or Phase II ERA documentation and Module 1.6 submissions – tailored to meet EMA and other relevant regulatory body requirements.
Post-Submission Support
We provide robust defence and support throughout the regulatory review process, addressing any issues that arise post-submission to facilitate approval.
Additional Regulatory Services
Pre-Testing QSAR Evaluation
We use QSAR models to predict fate and effects, aiding in budgetary forecasts and the development of targeted testing strategies.
Data Mining & Literature Reviews
Our team performs extensive literature searches and data mining to gather relevant data and identify structurally related molecules, enhancing the robustness of our assessments.
CRO Liaison
We coordinate with Contract Research Organisations to obtain quotes and schedule studies efficiently, ensuring your project remains on track.
Human Pharmaceutical Risk Assessment
We specialise in environmental risk assessment services for human pharmaceuticals, ensuring that new and generic medicines meet the stringent requirements set forth by global health authorities. Our team are adept at overcoming challenges relating to the drug approval processes, from initial development through to market authorisation. We focus on comprehensive risk assessments, regulatory dossier preparation, and strategic compliance management to support the development and registration of safe and effective medical treatments for human use. Our services are designed to streamline the regulatory pathway, reduce time to market, and ensure patient safety is never compromised.
Veterinary Pharmaceutical Risk Assessment
Our expertise extends to the regulatory needs of veterinary pharmaceuticals, where we assist clients in bringing innovative and essential animal health products to market. Understanding the unique challenges of veterinary drug approvals, Blue Frog Scientific offers tailored solutions for environmental risk assessments. We support the entire registration process, ensuring compliance with veterinary-specific regulatory standards aimed at safeguarding animal health and, by extension, public health through the responsible use of veterinary medicines.
If you’d like regulatory support for your pharmaceutical products, call and speak with one of our pharmaceutical specialists today and we’ll explain how our services can be tailored to meet your specific regulatory and scientific needs.
