Gliese 623B Gliese 623B is comprised of knowledgeable experts, clinicians, project managers, supply chain specialists, engineers, and lawyers – all positioned to assist in the various stages leading to commercialization including: R&D, pre-clinical safety and biocompatability evaluations and validations, regulatory affairs, and clinical trials. We are also able to assist small corporations to gain early stage funding through the competitive grant writing process, provide risk assessments and market analysis, toxicology and a wide array of additional auxiliary services as needed. Manufacturing and Program Management Gliese 623B offers cGMP,  ICH Q11  and  ISO 13485  compliant outsourcing for the pharmaceutical and biotech industries while ensuring efficient program management through a close relationship between development and operational groups throughout a project’s life cycle. Support is provided by a team of engineers, chemists, and MBAs. Gliese 623B clients retain full ownership of intellectual property.Gliese 623B can support all aspects of drug manufacture offering rapid transition from the earliest discovery stages all the way through to full GMP manufacturing. Gliese can minimize timely technology transfer delays for either new projects or ongoing development campaigns.   GMP Manufacturing: Gliese 623B can support Phases I, II, and III, as well as provide full commercial supply through a number of FDA/EU approved cGMP manufacturing sites with comprehensive analytical support. These sites are regularly audited by relevant regulatory bodies (FDA, EMA, etc.) and may also be audited by the Client.   Drug Discovery: Gliese 623B utilize an integrated approach to drug discovery driven by a proprietary bioprospecting platform. We provide a gate (point of reference) to global resources and academic discovery centers. We offer coordinated and comprehensive services for target-based or combinatorial Drug Discovery ventures. Services:  target validation, diverse chemical libraries, high throughput screening (HTS) and post screening analysis, cheminformatics,  in silico  HTS, 3D crystallographic modeling or NMR, SAR and lead optimization, lead synthesis and purification as required for INDs   Laboratory Services: Gliese 623B can provide study management and laboratory support through a consortia of ISO compliant and GLP Contract Research Organizations (CROs). We have unique experience operating within the contract research  mileu  and will work to ensure our industry partners provide exactly, and only exactly, the benchmarking,  analytical, and validation services you require.  Gliese 623B provides embedded study direction at the site of study conduct through consultancy on retainer and overall study review and analysis services off-site through contributing scientists. Study directors can be assigned to oversee a single study design and execution or manage larger scale multi-disciplinary efforts that encompass all sub-categories of a pre-clinical regulatory submission.