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CLINICAL STUDY SUBMISSIONS

Donawa Lifescience Consulting (DLC) > Clinical Study Submissions > EU Competent Authority and EC SUBMISSIONS

EU Competent Authority and EC Submissions

DLC Clinical Regulatory Unit services include:

  • Determination and interpretation of applicable country specific rules in all EU Member States for approval of:

> clinical studies with medical devices
> clinical performance studies with IVD medical devices
> biological sample collection studies
> other types of research settings (e.g. compassionate use procedures)

  • Writing / review of submission documents (i.e., study protocol, informed consent, Investigator’s Brochure, Case Report Form, other documents) for compliance with EN ISO 14155, General Data Protection Regulation (GDPR), and country-specific requirements
  • Regulatory review of technical documents, such as, Risk Analysis, Instructions for Use, Essential Requirements Checklist, or other documents for compliance with applicable regulatory requirements and/or standards
  • Notifications / submissions of clinical study documents to EU Competent Authorities and Ethics Committees
  • Submissions of amendments, yearly reports, etc. to Competent Authorities and Ethics Committees, as required
  • Certified translations of study documents from / to all European languages

The DLC Clinical Study services are managed from our headquarters in the historical centre of Rome, Italy. Contact us either by e-mail for a confidential discussion about your project, or call Daniela Karrer, VP Operations and Clinical Affairs, on +39 06 578 2665.

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