Quality Assurance
High-quality services based on the "fit-for-purpose" approach
Our laboratory is accredited according to ISO 17025 and all analytical procedures comply with the relevant legal requirements (GCP).
An independent quality assurance team is involved in every bioanalytical project, from start to completion. Regular inspections by both sponsors and authorities lead to a continuous review of our compliance.
GBA Group offers development and validation of bioanalytical assays according to the latest FDA and EMA guidelines. Our experienced bioanalytical scientists ensure a high-quality service based on the "fit-for-purpose" approach that meets the needs of the study:
- Exploratory Analysis
- Partial Validation
- Full Validation
All laboratory duties are specified in study-specific bioanalytical protocols that are established during the initiation stage of the project. Analytical data is stored and managed by the use of GCP and FDA 21 CFR, part 11 compliant laboratory database. Laboratory results and statistical evaluations are documented in standardized bioanalytical reports.
Special Analysis
GBA Group provides an analysis adopted by the sponsor. Almost anything is possible.
An example is a clinical trial in which menstrual blood loss has to be quantified (MBL).
Fewer than a handful of laboratories worldwide are able to quantify menstrual blood loss, GBA Group is the only one to offer the complete package of supply, logistics and analysis. Even new hygiene products (tampons and pads) with superabsorbent polymer cores can be analyzed in a sophisticated special process.
Another example is a special coagulation assay. Thanks to our flexibility, we can offer almost any test on any device.
Your direct contact
Tess Diskin
Director of Business Development
+1 508 475 8209
T.Diskin@gba-pharma.com
