DnA Technologies supports manufacturers of medical devices, combination products and in vitro diagnostic (IVD) medical devices, making their work easier.
Phase I. / Bioequivalence
DnA Technologies has strategic partnership with Phase I. clinical units in Croatia. In this co-operation we are responsible for regulatory affairs management and monitoring of the study, while the clinical units are performing the volunteer recruitment and treatment.
Phase II.-IV Clinical Trials
DnA Technologies is an experts in the planning and delivery of clinical research, we understand the importance of time, cost and quality, and can guarantee these metrics are met.
Feasibility – Site Selection – Study Start Up – Project Management – Clinical Monitoring – Vendor Management – Pharmacovigilance – Medical Monitoring – Quality – Legal Representation – Regulatory Services – Consulting Services – Flexible Resourcing
DnA Technologies provides a full regulatory service, including the preparation of all regulatory documentation and the provision of regulatory advice on: Registration strategies, Regulatory support of clinical trials, New Drug Applications (NDA), Compilation and maintenance of Marketing Authorization Applications
Monitoring the safety of medical product is crucial to their success and the reputation of the company. DnA Technologies provides services to support both clinical trials and post-marketing safety surveillance.
QA Site Audit Preparation
DnA Technologies is experienced in preparation for auditing the clinical trials GCP and protocol compliance, as well as the compliance with the local regulatory requirements. We offer a service to prepare the sites for internal audits (internal processes and systems), pharmacovigilance audits, third party vendor assessments.