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Since 1997, KABS is offering a broad range of product development services to the pharmaceutical industry, worldwide. Our team of more than 150 specialists support development programs from initial discovery to phase III and commercialization.

Our GMP compliant services include strategic planning, pre-clinical development, analytical testing, formulation development, manufacturing of prototypes and clinical supplies, distribution of clinical supplies to clinical sites and CMC aspects of regulatory affairs.

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Materials Synthesis and Characterization Parenteral injectable Method development and characterization Method development HPLC Raw material Analytical testing Test methods for new drugs Aseptic manufacturing of complex liquid Lyophilized parenteral products Complex oral dosage forms Impurity profiles of new drug substances Process Chromatography Solutions Purification procedures for biopolymers Formulation development Stability studies Pre-clinical development Formulation development Lyophilization Forced degradation Development of bioprocesses Chromatography Solutions Late-stage clinical trial materials Pre-formulation Monoclonal antibody, Biotechnology Biologics Compatibility studies Bioprocess Drug manufacture New drug discovery Phase I clinical trial materials Late-stage clinical trial materials Malaria drugs HIV drugs Ophthalmic solution Nitisinone Tyrosinemia type 1

With state-of-the-art instrumentation and cutting-edge ICP mass spectrometry equipment, KABS analysis services offer effective and precise quantification and identification of elements in a wide range of materials across diverse industries and applications. Since the key to accurate ICP analysis lies in proper sample preparation, our advanced sample preparation expertise ensure effective sample prep and reliable results.With sustained commitment, we help you make sense of your results, simplifying data interpretation.

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Thanks to the comprehensive scope of our global spray drying facilities, KABS is uniquely positioned to provide unparalleled scale-up capabilities, all within one network. From preclinical development to commercial manufacturing, we can provide spray drying services and solutions spanning from grams to tones. Additionally, we have the necessary infrastructure in place to safely spray dry both low- and highly-potent compounds alike, offering biopharma companies a range of capabilities for their APIs. By integrating API development and manufacturing, spray drying, and drug formulation under one roof, KABS provides biopharma companies with end-to-end expertise and experience and continuous support at every step.

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With sustainable partnerships in mind, KABS promotes analytical continuity in testing impurity profiles of new drug substances and corresponding new drug products. This is a key component of successful CMC section of regulatory submissions. All analytical testing activities performed at KABS are executed in cGMP compliant facilities audited by Health Canada, USFDA, European QPs. We develop and validate stability indicating test methods for new drugs. KABS is a WHO prequalified Quality Control Laboratory.

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In essence, KABS supports pharmaceutical companies at every step of the way, from drug development to commercial manufacturing, allowing them to focus on core competencies, such as research, discovery and marketing. KABS is a one-stop-shop for biopharma companies, allowing them to outsource a significant portion of non-core operations. KABS Integrated CDMO offerings offer a wide range of services which can include everything from pre-formulation, formulation development, stability studies, method development, pre-clinical to late-stage clinical trial materials, scale-up, registration batches and full-fledged commercial production.

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As a contract research organization (CRO), KABS provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. KABS provides such services as biopharmaceutical development, biological assay development, commercialization, clinical development, clinical trials management, pharmacovigilance, outcomes research, and real-world evidence.

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KABS pharmaceutical proficiency testing programme is recognised as a demonstration of laboratory quality and competency by a range of third parties, customers, regulators, and accreditation bodies. Our EDQM proficiency testing therefore plays an essential role in the complex regulatory framework for medicines in Europe. Its primary purpose is to protect public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use.

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