REGULATORY AND CLINICAL SERVICES: FROM BENCH TO BED

A FULL SERVICE CRO OBTAINING PREDICTABLE OUTCOMES, ON TIME AND BUDGET

1MED is an ISO 13485 certified provider of Regulatory, Quality and Clinical Trial Management services to the life sciences industry, with an in-house expertise in the Development and Approval of medical devices, combination products and in vitro diagnostics.

We are a multi-disciplinary team with over 35 years of experience and a consolidated background in full service Medical Device Development and Testing, Regulatory Affairs & Quality Assurance, Product and Company Certification and Clinical Trials Management.

Fully bespoke outsourced model

1MED supports its clients throughout the entire lifecycle of their products. Whichever your goals are, we help you reach them in a predictable, affordable and timely manner.

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Pre-Clinical and Clinical trial planning

1MED knows how to plan, manage, and whom to ask for reliable, useful, and repeatable pre-clinical and clinical results for smooth Regulatory Approval. Design, set up and execute pre-clinical and clinical trials for Drugs and Medical Devices without overlooking regulatory challenges.

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Regulatory Affairs & Quality Assurance

Staying on top of changing regulatory guidelines and requirements is a must. Paying attention to emerging trends in submission procedures and technologies is a bonus. 1MED does both. Don´t get caught up in a regulatory quagmire.

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Product or Device & Pharmaceutical Product Development

An innovative Drug or medical device will not achieve certification without adequate planning and support. Let 1MED work with you to grow your idea and to bring your product to market. During the entire lifecycle of your pharmaceutical product or medical device, 1MED will assist you with a range of strategic tailored solutions.

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