Clinical and non-clinical expertise:

Clinical Expertise:

Strategic Clinical Development:

We provide strategic guidance on designing and executing clinical trials that meet regulatory requirements and align with your product’s development goals.

Our experts help you define the most appropriate endpoints, patient populations, and study designs to maximize the chances of regulatory approval.

If you have already conducted your clinical trial and you just need support to compile Module 2 we can do that too.

Clinical Trial Applications (CTAs):

ERA assists in preparing and submitting CTAs, ensuring that all documentation complies with regulatory guidelines.

Our team facilitates communication with regulatory authorities to address any clinical trial-related queries or concerns.

GCP Inspection Readiness:

We prepare your organization for Good Clinical Practice (GCP) inspections, ensuring that you are inspection-ready at all times.

In the event of an inspection, our experts provide attendance and response support to address regulatory findings effectively.

Non-Clinical Expertise:

Comprehensive Non-Clinical Strategy:

Our non-clinical experts can develop a comprehensive strategy for your product’s non-clinical development, including toxicology studies and safety assessments.

We ensure that non-clinical data is robust and aligns with regulatory requirements.

We can also assist you with Module 2 writing and provide reports from our experienced experts which can do straight into your dossier.

Environmental Risk Assessment:

ERA specializes in environmental risk assessments, helping you navigate the evolving regulatory landscape in relation to pharmaceuticals and the environment.

We provide guidance on conducting environmental impact assessments and developing environmentally friendly product profiles.