Strategic considerations for implementing the revised EMA guideline on FIH clinical trials

First-in-human trial?

Zwiers Regulatory Consultancy is proud to have contributed to the article: “Strategic considerations for implementing the revised EMA guideline on FIH clinical trials” in the special June issue of TOPRA Regulatory Rapporteur on Clinical Trials.

Find out how to implement the updated EMA guideline in your strategy; check out the Regulatory Rapporteur.

Regulatory Rapporteur is available to download for TOPRA members.

Swift FDA and EMA submission guaranteed with eCTD platform

Viroclinics Biosciences and Zwiers Regulatory Consultancy are partnering to ensure regulatory compliant and submission-ready documentation. Their eCTD platform allows smooth preparation towards marketing approval and prevents unnecessary post-approval changes.

The complex and increasing set of requirements and regulations, urges companies to structure data submissions to regulatory authorities such FDA and EMA. Viroclinics has extensive experience in providing up-to-standard SOPs for analytical methods (i.e. method-SOP). Zwiers has the expertise to transfer these into regulatory compliant documents in line with all electronic Common Technical Document (eCTD) requirements.