Line of Business (LOB)

LOB 1: Medical Writing Regulatory and Development

LOB 2: Regulatory Strategy

LOB 3: Scientific Advice Meeting

Background

Client wanted to register drug device product in EU and US with limited Non-Clinical and Clinical Data.

Client Challenges

  • Lack of clarity on EU and US Regulatory Strategy.
  • Unsure of Legal Basis to approach for Registration. In EU, Article 8(3) Mixed.
  • Lack of information on Non-Clinical and Clinical Data required.
  • Length of the study, end point of the study vs claim was discrepant.

Solution provided by PLG

  • Harmonized Regulatory Strategy for EU and US.
  • Identify legal basis for application.
  • Bibliography justification for toxicity and clinical study.
  • Justification of quality of the medicinal product and device material.
  • Recommended comparable product as RLD and clinical studies.
  • Organized scientific advice with MHRA and represent the client in the meeting.

Benefits

  • SAM allowing for full clarity on the nature of the product and required information for successful registration in the EU.
  • Strategy map allowing client to maneuver the regulatory landscape, maintaining proposed budgets for registrations in EU and US.
  • Prepared justifications permitting the client to avoid costly Non-Clinical and Clinical studies.

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Drug Device Combination Product for EU and US – Progesterone vaginal ring, Italfarmaco