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Regulatory

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Overview

As a company with significant international exposure, we fully understand the critical value of regulatory operations in the success of a Clinical Trial. As such we have invested heavily in building our international regulatory team to ensure local expertise throughout continental Europe.

HeaDS has been involved in regulatory interactions with Competent Authorities, at national and regional level having undertaken a multitude of clinical trials, including international pivotal phase 3 multicenter trials.

Our international team of experts will ensure a smooth and timely regulatory approval of your Clinical Trial in compliance with all applicable regulatory requirements.

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Services

  • Design and implementation of regulatory submission strategy
  • Collection and preparation of key submission documents
  • Development of country specific submissions package
  • Localization of master ICF
  • Negotiation of clinical trial agreements
  • Preparation and submission of clinical trial application (CTA)
  • Submission and notification of substantial and non-substantial protocol amendments
  • Management of communications with regulatory agencies and ethics committees
  • Responses to regulatory body requests for information
  • End of trial notifications, submission of any country specific requirement
  • Regulatory Project Management (management of timelines; oversight of contract vendors)
  • Support in other study registration activities (local registries, ClinicalTrials.Gov)
  • Facilitate submission of compassionate use programs, early access and named patient programs

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