We Combine Academic Knowledge With Legislative Requirements
Our Services Are Underpinned By Our Culture And Expertise In Regulation
Qualified experts (former members of the National Agency, EMA and EDQM committees) can provide high level scientific guidance for the Quality, Clinical and Non Clinical parts throughout the pharmaceutical products’ lifecycle.
EMA or National Agencies’ Scientific Advice
Data Gap Analysis
Letter of Deficiency Response / Arbitration Guidance
Legal Basis and Regulation Strategy