Custom molecular diagnostic and immunoassay contract development & manufacturing


MDG, your European IVD partner

MDG (Molecular Diagnostic Group) along with its German subsidiary, Biotype, is specialized in developing and manufacturing in-vitro diagnostic (IVD) products  especially molecular diagnostic and immunoassay solutions. Thanks to our US and German locations, we are helping US IVD companies to rapidly access the European IVD market by offering a wide range of solutions.

Molecular and immunological diagnostic service provider

Biotype in-vitro diagnostic is a fully integrated CDMO specialized in molecular diagnostic and immunoassay of RUO, prototypes and IVD products. Biotype offers custom development and manufacturing services of a wide range of solutions for the detection and/or quantification of DNA, RNA and biomarkers.PCR and ELISA custom manufacturing

EU-Compliance – Fully compliant with new EU IVDR (European in-vitro diagnostic regulation 2017/746)

Our QMS (Quality Management System) meets the requirements of the national and international norms ISO 9001 and ISO 13485 for the sales, development, manufacturing and services of molecular tests for research and in-vitro diagnostic applications.

• Application & CE Registration
CE IVD labeling_in-vitro diagnostic
• IVDR support

Operations – We have mastered each step of the process to launch products on the European market in a rapid and cost-effective way

Global project management through a dedicated team of in-vitro diagnostic scientists, EU IVDR quality and regulatory experts as well as European IVD sales managers. Our Custom Solutions Team will be there from first contact to delivery of your product.

• Pre and Post PCR reagents
• Liquid or lyophilized (various volumes from 5ul to 100 ml in tubes, strips, plates or bottles)
• Scalable production
• Modern facilities
PCR polymerase chain reaction
• Raw materials procurement/supplier network
• Quality control
• Storage and logistics traceability
• Stability and transport studies
Custom development and manfacturing of in-vitro diagnostic assays Packaging:
• Manual or high throughput automation (10 to 24,000 vials/day)
• Kit assembly
Flexible scale format:
• Small and large batches
• Labelling to align with your corporate identity

Development – The standard workflow includes a feasibility study, optimization phase, and validation

Fully equipped to manufacture IVD Buffers, Primer Mix, Positive controls, Enzymes, Size and Matrix Standards in state-of-art laboratories (Biosafety level BSL-2, Genetic Engineering Safety Level (S1), Clean room (Class C). Our facility design allows a unidirectional workflow to minimize in process contamination risks and follows the rules of good laboratory practice (GLP).

• Assay validation
• Full range of biomarkers and flexible platform technologies
qualitype GmbH
Performance Evaluation:
• Analytical and Clinical performance studies
• Robust testing and performance evaluation

Commercialization – Our broad experience encompasses production of a marketable CE-IVD and ensures efficient and smooth market entry

With more than 100 collaborators, the company based in Dresden is producing hundreds of IVD reagents and molecular diagnostics kits per year in various applications: oncology, infectious diseases, forensics, and veterinary.

In-vitro diagnostic European authorized representative definition Distribution:
• Supply chain management
• Collaboration networking

Expertise – Extensive experience in the field of PCR molecular diagnostics and in-vitro diagnostics

With over 20 years’ experience, we have successfully positioned ourselves as trusted providers of state-of-the-art solutions for molecular diagnostics in Europe.

• Trustworthy & reliable communication
• Flexibility and rapid implementation
• Transparency
• High commitment
Biotype Innovation GmbH

Our subsidiary, Biotype, is based in Germany which is the largest in-vitro diagnostic market within Europe. This central position in Europe is ideal for developing the global European market efficiently. Thanks to our senior business development team and European IVD distributor network, we ensure a fast commercialization of molecular and immunoassay in-vitro diagnostic kits and reagents.

Get onboard and have a safe journey to Europe with MDG!

Visite Biotype in-vitro diagnostic custom solutions

Discover our other subsidiaries:

qualitype GmbHSoftware solutions for laboratory
and manufacturing
ROTOP Pharmaka GmbHRadiopharmaceutical products

Contact us to tackle the European IVD market

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