Project Definition

CUSTOMER REQUEST

Acknowledging your needs and demands

Project Definition

PROJECT DEFINITION

Building a multidisciplinary project team of experts that will determine a complete solution, timeline, and appropriate technologies

Contract Development

CONTRACT DEVELOPMENT

Developing the product according to your needs: Prototype, RUO, or CE-IVD

Contract Manufacturing

CONTRACT MANUFACTURING

Manufacturing at different scales: small or large batches

Validation

VALIDATION

Clinical validation of the specificity and sensitivity of your product

Custom Packaging

CUSTOM PACKAGING

Customized packaging of your product

Technical Support

TECHNICAL SUPPORT

Continued support throughout the life cycle of your product

Advantages You Can Trust

Dedicated Project Team

For each contract development and/or manufacturing project, we assemble a multidisciplinary team of experts that accompanies you throughout your individual project.

Transparent Project Management

Project goals and timelines are jointly set, and you will be regularly updated of our progress during web-based or on-site progress meetings.

ISO Certified

Our quality management system fulfills national and international norms (ISO 9001 and ISO 13485) for the development and the production of molecular biological diagnostic tests.

EXPERTISE YOU CAN RELY ON

Research, Development, Manufacturing

You can rely on a company that brings over twenty years of expertise in research, development, and manufacturing of in vitro diagnostic (CE-IVD) products.

Diversity in Indications

Benefit from our expertise in the diverse fields of molecular and immunoassay-based diagnostics. We have a proven record in developing molecular and immunoassay diagnostic tests in various applications, such oncology, infectious diseases, forensics, and veterinary.

Regulatory Compliance

We actively work with you to manage project related regulatory aspects, provide guidance and help navigate the often-perplexing environment of industry regulations.

SOLUTIONS YOU CAN CHOOSE

Platform Flexibility

We provide a wide range of molecular diagnostic and immunoassay platforms for the detection and quantification of biomarkers at various levels of multiplexing.

Complete IVD Realization or Elements

Biotype addresses all the aspects of product development and manufacturing, right from the idea to the large-scale production of a marketable CE-IVD. You decide whether you want us to support you throughout the entire process or only during certain steps and phases of the product life cycle.

Small- / Large-Scale Requests

Your project scale is entirely customizable. With our Contract Manufacturing services, we provide small batches for clinical studies or large batches for international commercialization. With our Contract development services, we accommodate for small or large sized projects.