SEQ Regulatory Services: Readability User Testing Compliance

  • Directive 2001/83/EC Compliance with SEQ Readability User Testing

  • Comprehensive Services for All Product Types

  • From Protocols to Submission-Ready Reports: SEQ Quality Standards

Welcome to SEQ Regulatory Services, your partner in achieving compliance with Directive 2001/83/EC through comprehensive Readability User Testing. Our services cover all product types, including devices and dosage forms.

 

  • Quality Standards Throughout the Process: At SEQ, we establish quality standards from writing protocols and questionnaire development to critical assessment, review of existing leaflets, and designing leaflets. We create templates for product portfolios, ensuring consistent quality across your offerings.

  • Comprehensive Service Offering: Our services encompass recruitment of test participants, pilot testing, and one-to-one interviews. SEQ specializes in writing final “submission-ready” reports and providing bridging reports, both abridged and full (focus testing), for successful compliance.

  • EU-Wide Success: Successful Readability User Testing reports have been generated for all product presentations, covering National, Centralized Procedure (CP), Mutual Recognition Procedure (MRP), and Decentralized Procedure (DCP) submissions throughout the EU.

  • Efficient Strategies for Large Portfolios: For companies with extensive portfolios, SEQ develops testing and bridging strategies aimed at reducing time and costs while ensuring compliance.

For more information, contact us at enquiries@nerin.co.im.

Feel free to let me know if you have any further requests or adjustments!

  • Writing Protocols and Questionnaire Development

  • Critical Assessment and Review of Existing Leaflets

  • Designing Leaflets and Creating Templates for Product Portfolios

  • Recruitment, Pilot Testing, and One-to-One Interviews

  • Submission-Ready Reports and Bridging Strategies