Development and validation of analytical methods - qualification of laboratory equipment

Scientific services for laboratory and analysis

We develop new analytical methods on behalf of customers and relieve research and development laboratories by taking on an increased workload.

We develop independent solutions in the field of analytical methods in the laboratory.

We provide competent, state-of-the-art advice in accordance with normative specifications and ensure conformity according to applicable guidelines and ordinances by validating your analysis methods and qualifying your laboratory equipment.

Portfolio of scientific services

  • We break down complex structures into their individual components and examine their characteristics. EXCO specialists carry out systematic investigations on your behalf and analyze them with task-specific tools and methods.

  • We develop high-performance analytical methods for characterizing and evaluating input and raw materials with regard to their purity or reactivity. We develop independently, optimize existing methods or support the development of suitable methods for determining materials.

  • We reliably develop new immunoassay analysis methods for patient-side laboratory diagnostics. To do this, we configure assays to detect antigens. Method validation carried out by experts in accordance with GMP compliance guidelines is the guarantee for minimizing the risk of damage and ensuring economic success.

  • We validate analytical methods and qualify analytical devices alongside the development or retrospectively. We work in accordance with the guidelines of GMP compliance and create all the documents that accompany the validation, including validation plans and reports.

  • We provide our partners in the fields of pharmaceutical and medical technology with support to conduct clinical studies. We prepare the studies, plan the implementation, support the production of the document data and evaluate them.

  • We are specialists in the validated relocation of biotechnological laboratories and analytical equipment. From planning with tried and tested workflow plans to coordinating other suppliers to implementation and subsequent validation, we ensure that complex analytical laboratory devices are relocated smoothly.


What our customers appreciate

Tried-and-tested validation concept

  • One person responsible for the project from the draft concept and validation activities to the validation report
  • Suitability test of the analytical method used
  • Optimizing the method
  • Reporting using our own templates or customer-specific templates

The strengths of our employees

  • Many years of experience with industry-typical methods and regulatory topics
  • Constant training and qualification in quality, risk and process management according to EXCO training guidelines
  • Strong commitment due to high motivation and identification with the projects
  • Analytical planning and forward-thinking

Project Reference

Lab Relocation

A university hospital has to move labs and offices of ten biomedical institutes. EXCO plans and manages the relocation project from preparation to final execution.

Project Reference

Re-Validation

A manufacturer of pharmaceutical products needs a revalidation of analytical methods for the approval of raw materials, after their supplier was changed.

Project Reference

Compliant Quality Documentation

A manufacturer of parenteral nutrition products for premature babies wants to supply its products in the USA. All the quality documentation must be adjusted for this.