Dr. Thomas Lange, Founder GxP-Agentur (Pharmacist)
As founder and main visionary, Thomas is the driving force of the GxP-Agency. His goal is to develop the GxP-Agency with the best possible services and know-how in Quality and Regulatory Affairs. He is focused on setting up the QMS for new companies in the pharmaceutical environment in Germany and Switzerland. He is qualified as QP/fvP/RP.
Dr. Hans-Georg Häcker, Consultant GxP-Agentur (Pharmacist)
Hans-Georg is an expert in production (Black Belt) and quality management. With his knowledge in the field of process optimisation, he always keeps an eye on profitability and increasing efficiency. His diverse experience of many years at a production site is his recipe for success for successful inspections (FDA, ANVISA, RP etc.) as well as for customer audits. He is qualified as fvP/RP.
Dr. Franziska Häcker, Consultant GxP-Agentur (Pharmacist)
Franziska's areas of expertise are narcotics, GDP and quality management in the hospital sector. In the production environment (GMP) she can support our customers with her specific knowledge in project management of NPIs and transfers. Efficiency and compliance in pharmaceutical processes are her strengths. She is qualified as fvP/RP.
Dr. Xiao Yu Xie, Consultant GxP-Agentur (Pharmacist)
Xiao Yu is our expert in the development, validation and transfer of analytical methods such as dissolution & HPLC. He has great expertise in quality management of contract laboratories (QC). He speaks fluently German, English, French and Chinese which is very much appreciated by our international customers.
Anke Latza, Consultant GxP-Agentur (Technican & B.Sc.)
Anke helps us with her many years of GMP and GLP experience in laboratory and production. Her core competencies are in the area of optimization of MBRs and performance of BRRs.
André Schmidt, Strategic Marketing
André has been advising companies on strategic marketing since 2009. With his in-depth knowledge and his media agency Somengo (http://somengo.de/) he helps to bring measurable and sustainable success to the GxP agency's projects.
Our services
Establishment and maintanance of Quality Management Systems (QMS) GMP/GDP
Establishment and maintanance of operating licenses GMP/GDP
Compilation of Standard Operating Procedures (SOPs)
Supplier Qualification - Execution of external and internal Audits as well as establishment of Quality Agreements
Product Quality Review (Preparation, Review, Oversight)
Interim Quality Management incl. QP/FvP/RP
Batch Certification / Release
Process Optimization and Harmonization of QMS Processes: e.g. Complaint Managment, CAPA-Management, Training System
Preparation of Inspections and Audits
MAH in Foreign Markets based on Swiss MA
Submission and Maintenance of Regulatory Dossiers (CH)
Responsible Person Advertisement (CH) / Information Officer (DE)