Quality Assurance

High quality service based on the “fit-for-purpose” approach

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

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 GCP and FDA 21 CFR, part 11 compliant laboratory database. Laboratory results and statistical evaluations are documented in standardized bioanalytical reports.

Special Analysis

LKF provides sponsor adopted analysis. Nearly everything is possible.

One example is a clinical trial with the need to quantify the menstrual blood loss (MBL).

Less than a handful laboratories worldwide are able to quantify the menstrual blood loss, LKF is the only one who can cover the whole package of supply, logistics and analysis. Even new sanitary products (tampons and pads) with superabsorbent polymer core can be analyzed in a sophisticated special way.

Another example is a special coagulation assay. Due to our flexibility we can offer nearly any test on any device.