Clinical Regulatory Services
Streamlining clinical investigation approvals
Handling the complexities of clinical investigation approvals can be daunting. We streamline the process, ensuring you get the green light to start your study efficiently and in full compliance.
What are clinical regulatory services?
Clinical regulatory services encompass all the approvals and submissions required to initiate and maintain a clinical investigation. This includes submissions to competent authorities, ethics committees, and other national bodies applicable to your study.
Country-specific knowledge is essential to prepare a good submission package and optimize the review process. Compliance with regulations and guidelines such as MDR, GCP, ISO14155, GDPR, and national legislation is crucial for both approval and the successful conduct of your study.
Why is it important?
Under the MDR, stricter requirements and tighter timelines make it crucial to have a thorough understanding of both European and country-specific regulations.
Identifying study type
Identifying the type of study and involved authorities.
Ensuring compliance
Ensuring compliance with all relevant regulations.
Country-specific submission
Managing country-specific submission processes.
Avoiding delays
Avoiding delays by preparing complete and accurate submission packages.
Gaining approval
Gaining approval for both applications and modifications or reports during the study’s lifecycle.
How can QbD Group support you?
We provide tailored support to sponsors and manufacturers, from small startups to large medical device companies.
Submission strategy
Guidance on the best submission route and strategy to align with your goals and timelines.
Submission requirements
Clear documentation of what’s needed, including templates and document support.
Submission preparation
Compilation of complete submission packages, including essential documents like cover letters, IFUs, GSPR checklists.
Submission execution
Direct handling of submissions, including expertise in country-specific portals and processes.
Approval follow-up
Follow-up until approval, assistance with responding to requests for information.
Ongoing support
Amendments, modifications, and reporting throughout the study until the final study report is complete.
Why QbD Group
Your trusted partner
Our service supports the entire study, from initial approval through reporting and modification submissions, all the way to the final study report.
Strategic insight: we help you with your submission strategy that aligns with realistic timelines.
Regulatory expertise: we ensure your submissions are complete, accurate, and adhere to necessary regulations.
Hands-on support: from initial submission to responses to authorities’ requests, we handle every detail.
FAQ
Frequently Asked Questions
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