HOME BCR Lab _____________________________________________________________________________ Welcome to BCR Lab BCR Lab is an independent and accredited laboratory for analytical

testing. BCR Lab is known as one of the most experienced and skilled testing laboratories tha t specialize in various kinds of analyses. BCR Lab is registered by FDA and work s in compliance with the Code of Federal Regulations. BCR Lab possesses particul ar experience in carrying out different analyses using all existing methods appr opriate for the performed analytical testing. Testing Methods of BCR Lab Offering customized services BCR Lab endeavors to satisfy all clients requirements. Our professionals in analytical testing are skilled and experienced at identify ing and understanding particular customer needs and solving exceptionally diffic ult problems. BCR Lab services offer the sound basis for confirmation and specif ication of analytical results. Customers get precise and current pricing for all analytical tests that may be requested even before the sample submission. Poten tial clients can contact the BCR Lab Customer Department to discuss prices and a sk for a written price substantiation and estimation. Validation services of BCR Lab Validations are carried out in conformity with the contemporary International Gu idelines. BCR Lab develops and writes the validation protocols. Validation is as sociated with general project plan. Services of BCR Lab validation ascertain tha t the performance characteristics of any used analytical method are appropriate for the proposed task. BCR Lab determines all important characteristics such as accuracy, specificity, precision, linearity, reproducibility, detection and quan titation limits. Standard Compliance of BCR Lab Standard methods of BCR Lab are related to the extensive variety of existing bus inesses and industries. BCR Lab is registered by the Food and Drug Administration. BCR Lab performs anal ytical testing of food and color additives, drugs, products of biological origin , and medical devices. To determine their safety, these objects are analyzed in special test systems such as animals, plants, and microorganisms under laborator y conditions. BCR Lab carries out analyses supporting these laboratory approache s. All analytical information is controlled by the Quality Unit. BCR Lab keeps to the United States Pharmacopoeia standards for assuring high qua lity assessments. The United States Pharmacopoeia presupposes standards for medi cines, drug substances, excipients, dosage forms, dietary supplements, and medic al apparatuses. Medications must meet the Pharmacopoeia standards to stay away f rom potential misbranding and adulteration. BCR Lab also analyzes products that are controlled by Current Good Manufacturing Practice. The Quality Unit examines all records to guarantee that these tests c omply with all pertinent regulations. BCR Lab possesses a potent instrument vali dation system to guarantee that all tools applied in these analytical studies ar e qualified completely. Quality Assurance in BCR Lab BCR Lab keeps to all-inclusive Quality Assurance Regulations controlled by the m anagers and staff members. The Quality Department supervises all analytical test s to make certain that methods, records, and practices are in compliance with ri gid requirements and own internal standards of BCR Lab. Our Quality Regulations meet the terms of relevant laboratory requirements. BCR Lab offers services in a

ccordance with Good Laboratory Practices and other regulations. The working acti vity of BCR Lab is maintained by a tough system of inspections, controls, and va lidations. BCR Lab is also open for custom auditing. Quality Levels of BCR Lab The essential service level presupposes all-purpose testing, low-risk analyses, and non-regulatory tests. This level is appropriate for general and screening te sts in research and industries. Regulatory service level is good for broadly reg ulated industries in compliance with Food and Drug Administration demands. Custo m service level is intended for clients proposing their own plan and wishing tha t a particular system was applied in a suitable laboratory work covering multipl e quality requirements. _____________________________________________________________________________ _____________________________________________________________________________