Quality and Safety
Quality is our top priority. Our certified cross-departmental processes ensure consistent, high standards in every production, guaranteeing the safety and reliability of our products that our partners value.
Commitment to Quality and Product Safety at bitop AG
As an ISO 13485 certified manufacturer of high-quality raw materials and innovative finished medical devices, bitop AG upholds the highest standards in quality and product safety. Our comprehensive quality management system ensures compliance with international standards, while we continuously optimize our processes to guarantee the safety and reliability of our products.
Strict Quality Controls for In-House Manufactured Raw Materials
At bitop AG, we follow the rigorous standards we have set out as the leading manufacturer of lab-grown Extremolytes. Throught our measures, we ensure our raw materials for pharmaceutical and cosmetic appliances meet the highest safety, environmental, and quality requirements before reaching the market.
Purity Testing: Ectoin and Glycoin are subjected to advanced analytical methods to ensure their purity, confirming that they meet stringent specifications and are free from contaminants.
Batch Release Testing: Every batch of Ectoin and Glycoin undergoes rigorous testing, including stability, efficacy, and safety assessments, before it is approved for distribution.
Strict Quality Controls for our medEctoin Based Finished Products
To offer a broad range of finished dosage devices, we partner with renowned Contract Manufacturing Organizations (CMOs) primarily in Germany and Europe.
Selection: We carefully select and validate our CMOs and conduct regular audits to ensure compliance with ISO 13485 and our high standards.
Supplier Audits: Regular audits verify that CMO processes meet our standards and ISO 13485 requirements.
In-Process Quality Checks: CMOs perform continuous quality controls to ensure all production stages meet regulatory and quality standards.
Final Product Inspection: bitop conducts thorough inspections on finished products, including sterility, microbial safety, packaging, labeling, and overall conformity with ISO 13485 and product specifications.
Baby Safe
"At bitop AG, we are deeply committed to upholding the highest standards of quality across all aspects of our operations. From our in-house production of Ectoin and Glycoin to the close collaboration with our carefully selected, ISO 13485 certified CMOs, we ensure that every product meets stringent regulatory requirements and exceeds customer expectations. This dedication to quality is at the core of everything we do.
Because we care."
— Eva Galik, CEO of bitop AG
Learn More About Our Excellence
Glycoin® Natural
Glycoin® natural is a multifunctional anti-aging and cell-boosting active ingredient targeting tired, stressed or mature skin.
MedEctoin®
This powerful and technically straightforward ingredient comes with an extensive package of clinical studies...
Ectoin® Natural
This multifunctional active ingredient is able to prevent cell damage and inflammation caused by all sorts of stress factors, thereby preserving the skin´s beauty and health.