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WELCOME IN MEDISTRA

Elevating Healthcare Through Research Excellence

Partnering for excellence in clinical research and regulatory services.

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About us

Who are we

Medistra was founded with a vision to transform clinical research and regulatory processes. We built a reputation for excellence, driven by our commitment to innovation and strategic partnerships. Our team of experts has navigated complex regulatory landscapes, ensuring successful outcomes for our clients. Today, Medistra stands as a trusted partner, dedicated to advancing healthcare through meticulous research and compliance.

 

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Foundation for Future Therapies

Medistra is a clinical research partner combining strategic regulatory expertise, efficient trial execution, and rigorous quality standards to help pharmaceutical, biotech, and medical device innovators bring safe, effective therapies to patients faster.

As a nimble, science-driven company, Medistra integrates seamlessly with your team, turning regulatory and clinical complexity into clear, actionable paths from early development to market approval.

 

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What we offer?

At Medistra, we offer comprehensive support in clinical research and regulatory affairs. Our expertise spans the entire research lifecycle, ensuring efficient study design, execution, and compliance with regulatory standards. We provide tailored solutions that enhance your research capabilities, streamline submissions, and facilitate successful trials. Our dedicated team is committed to fostering innovation and excellence, enabling you to navigate the complexities of the clinical landscape with confidence. Partner with us to transform your research ambitions into successful realities.

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Strategic Advisory For Innovation

Submissions And Lifecycle Support

Strategy And Planning

Consulting services, streamline development processes, and align regulatory, clinical, and business strategies to optimize program success and compliance.

Preparation, coordination, and maintenance of regulatory submissions and post-approval updates to ensure compliance with evolving regulations.

Comprehensive regulatory pathway design, including early development advice, classification, and submission planning aligned with clinical and commercial goals.

Navigating regulatory requirements can be challenging. Medistra offers expert guidance to achieve compliance and expedite market entry.

Ensuring Regulatory

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Quality and compliance frameworks

Clinical Trial Conduct And Oversight

Study Design And Protocol Development

We specialize in transforming innovative ideas into successful clinical trials. 

Advancing Research

Development and implementation of quality management systems, SOPs, and compliance practices aligned with Good Clinical Practice (GCP) to support reliable, ethical study conduct.

Full operational management of clinical trials including site selection, study start-up, monitoring oversight, vendor coordination, and risk-based quality management to ensure timely and budget-compliant execution.

Creation of scientifically robust protocols tailored for first-in-human, feasibility, pivotal, and post-marketing studies based on indication, risk, and regulatory requirements.

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Contact

info@medistra.eu

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