Know-how and Best Practice to Serve our Clients

Transcription

1 BioChem Analytical Laboratory Know-how and Best Practice to Serve our Clients

2 BioChem Analytical Laboratory Leading in all Disciplines One laboratory, three disciplines: Everything under one roof - competent, convenient, flexible. Superior analytical skills: Always the optimal application for your project and your budget. 2 4 High level of service: Short response time, highest deadline reliability. Individualized customer service readily available. 6 8 Technology database and knowledge pool: Know-how based on decades of experience Maintains all relevant allowances and certifications, GMP, GLP and FDA inspected and registered: Providing a broad range of services. 3 Flexible capacity: For fast and precise implementation at all times. 5 Excellent quality assurance: Highest level of transparency for your certainty. 7 Comprehensive consultation: We ll always have time for you. 9 Interdisciplinary exchange: Access to our network of experts.

3 Seeking Excellence? BioChem. As one of the leading contract laboratories in German-speaking regions we support enterprises and their products with physico-chemical, microbiological and molecular biological analytics. BioChem offers services with exceptional scientific competence and more than 40 years of experience in three core competencies: Analytics Microbiology Molecular Biology/Bioanalytics Comprehensive scientific know-how, superior process competence and a strong focus on customer satisfaction define the quality of our services. Always governed by: Safety is our guiding principle. Reliability one hundred percent of the time is our primary concern. Understanding our clients needs and exceeding their expectations is our goal. Day after day. If you are looking for the best of all possible solutions, contact us. Our experts gladly take time to speak to you. Anytime.

4 Customized Innovations Exceptional performance demands the ability to completely satisfy the customer s needs at any time. In this regard, BioChem has worked to meet the highest standard for more than 40 years during this time our service portfolio evolved continuously. As our service portfolio expanded, we also raised the standards we apply to the evaluation of safety, reliability and our scientific know-how. In this way we succeeded in developing a broad range of biochemical analytical techniques as well as a one-of-a-kind knowledge database, which originates and continuously feeds the development of new technologies and methods. Our experts closely collaborate with our clients during the development of these methods to assure the best fit for our clients needs and to provide each project with safe, fast and reliable service. When know-how merges with creativity and scientific curiosity combines with the needs of the client, custom solutions emerge innovations, customized especially for you. This is possible because BioChem maintained two basic values over the years: Close personal contact between project leader and client, which is indispensable for efficient and purposeful cooperation; and the flat hierarchical structure of a family business, where customer focus and enthusiasm are an integral part of the company culture. Now and in the future. The analytical laboratory for: all raw materials additives intermediate products finished products and pharmaceutical chemical cosmetic diagnostic products including dietary supplements medical products cytostatics narcotics

5 BioChem analytically accompanies your products through the entire course of your value chain ANALYTICS MICROBIOLOGY MOLECULAR BIOLOGY/BIOANALYTICS QUALITY CONTROL ANALYSIS COMPARATIVE DISSOLUTION SUBMISS EU-REANALYTICS DEVELOPMENT RESEARCH

6 LIFECYCLE SALES PRODUCTION ION ANALYTICAL DEVELOPMENT METHOD DEVELOPMENT/METHOD VALIDATION RELEASE-/STABILITY STUDIES REGISTRATION SUPPORT Our clients: R & D Pharmaceutical Industry Generics manufacturers Contract manufacturers and developers Suppliers Importers Start-up companies Research institutes Universities Clinics Pharmacies Pharmaceutical industry Medical device industry Chemical industry Cosmetic industry Diagnostic industry Biotechnological industry

7 Microbiology As part of the pharmaceutical quality control, microbiological tests are the main pillars of our company. These are the genes of BioChem, marked by the experience and expertise of longtime employees. They have contributed to making the microbiological department a sought-after resource in professional circles, known not only for speed but also for outstanding customer service. In addition to the broad spectrum of microbiological pharmacopoeia analysis, the microbiological department carries out a variety of special tasks, which it innovatively implements in theory and practice, always finding the right solution. Analytics High innovative strength and excellent technical equipment allow the analytical department to offer an extremely broad service range. With the use of special instruments such as e.g. HPLC with ELSD or electrochemical detector and GC-ECD, -WLD, or -PND, BioChem has established different niche technologies. Naturally, the conventional analytical techniques, such as HPLC, GC, AAS, ICP-MS, are established as well. This also applies to sample analysis with physico-chemical/wet-chemical methods in accordance with Ph. Eur., USP, JP or FCC. With a wealth of experience and know-how, obsolete methods required by pharmacopeia were reconfigured, such as the use of packed columns in GC. This is how BioChem sets industry standards. Molecular Biology/Bioanalytics Molecular biology/bioanalytics at BioChem covers a broad spectrum in GMP-compliant analysis of biopharmaceuticals from protein- and nucleic acid analysis, to special techniques such as enzymatic assays or capillary electrophoresis. Our experts develop their own methods, tailored to the respective problem, when not specified by pharmacopoeia. The methods are modified in such a way that the optimal method is used for each sample. Always thinking one step ahead to find solutions that were initially unthinkable, is in line with our understanding of customer service. Quality Management Anyone who stops improving, has stopped being good. [Philip Rosenthal] Quality management and -assurance are continuous processes at BioChem that exceed the requirements in the GMP and GLP areas and pharmacopoeia specifications. The industry diversity of our customers provides additional specific demands on our quality management. In regular audits, we gain their long-lasting confidence, not only in the security of our partnership with them, but also in the fact that we always find the optimal solution for every problem.

8 BioChem GmbH Daimlerstrasse 5b D Karlsruhe Phone + 49 (0) Fax + 49 (0) biochem@biochem.de