Bioanalysis

Our laboratory is certified according to ISO 17025 and all analytical procedures are in accordance with the relevant regulatory requirements (GCP/GLP/GMP).

An independent quality assurance unit is involved in every bioanalytical project, from the beginning to completion. Periodical inspections by sponsors and authorities lead to a continuous exploration of our regulatory compliance.

LKF offers bioanalytical assay development and validation following the most recent FDA and EMA guidance documents. Our experienced bioanalytical scientists ensure a high quality service based on the “fit-for-purpose” approach adopted to the study needs:

  • Exploratory analysis
  • Partial validation
  • Full validation

All laboratory tasks are specified in study-specific bioanalytical protocols generated during the initiation phase of the project. Analytical data is kept and managed by the use of LKF's GLP and FDA 21 CFR, part 11 compliant laboratory database. Laboratory results and statistical evaluations are documented in standardized bioanalytical reports.

 

Special Analysis

Meet our Team

Dr. rer. nat. Volker
El-Samalouti

Bioanalysis

Volker El-Samalouti - Bioanalytik

Special analytical questions in consideration of growing regulatory requirements are the main challenges in bioanalytics. Our team of experienced scientists provides to you substantial support for your needs.