Quality Assurance / Regulatory Affairs

In Europe (EU MDR), the US (FDA), or other across emerging markets, Kuwa Consulting Group SMEs have been involved in QA/RA activities which aim to prepare medical devices and newly developed pharmaceutical drugs for market entry. We are proficient in global CMS regulations and guidelines, have developed and maintained CMC strategies for post approval changes, site transfers, site additions and supported health authority queries to global marketing submissions. Our consultants have extensive expertise in CTD format and content as well as performing strategic analysis of legacy product dossiers in an effort to modernize such dossiers into global regulatory standards alignment. Our SMEs have hands-on experience in preparing technical and submission documentation such as (IFU, Risk Management report, Biocompatibility report, Clinical Evaluation Report, compiling INDs and IMPDs to the FDA and global regulatory agencies prior to initiation of clinical studies.