At Effimed, we know that regulatory efficiency and expertise is critical to every study. Our experts provide you with country specific regulatory guidance, document preparation, and submission management of clinical trial applications. We also provide support in auditing and training services across a clinical trial.

A complimentary service we offer is Regulatory Strategic Planning which incorporates our knowledge of clinical endpoints, adaptive trial design, regulatory guidelines and development trends in key drug and device indications.

Our functional knowledge incorporates experience gained from interaction with FDA, EMEA, DCGI, and various international regulatory authorities around the globe. Effimed’s regulatory intelligence keeps current on regulatory guidelines specific to document handling procedures, electronic submissions, 21 CFR Part 11 compliance, and disease specific guidance. Effimed has successfully submitted orphan drug applications, INDs, NDAs and Subpart H components, MAAs, BLAs, MLAs, 510(k)s, and PMAs.

Specific Service Suite:

• Country selection/regulatory timeline guidance
• Preparation, submission maintenance of clinical trial applications
• Independent Review Board liaison and management
• Trial Master File Audits
• Final Clinical Study Report (FCSR) Audits
• Medical/technical document review
• Database Audits
• Vendor Audits
• ICH/GCP training
• Clinical site & staff ICH/GCP Compliance Training
• FDA, EMEA, DCGI liaison
• QA Compliance Consulting