Pharmaceuticals - Woodbridge, Virginia, United States
Cambra Consulting Inc. is a niche woman-owned small business providing expert biopharmaceutical professional technical consulting services to government, industrial and nonprofit clients worldwide.CCI provides an integrated approach to de-risking the technical and regulatory challenges in the development and commercialization of biopharmaceutical products that improve patients' lives. CCI experts have had decades of experience within the industry and have extensive domestic and international contacts. We strive to exceed our clients' expectations and to be recognized for our technical excellence, thought leadership, integrity and outstanding service. Our services include: Manufacturing Strategy and Operations. CCI subject matter experts can evaluate and help clients strategize their manufacturing programs to deliver quality materials while providing the data required to support regulatory filings for clinical and market applications globally. Our CMC experts will help you strategize throughout all stages of your product's lifecycle. Quality and Regulatory. CCI has a depth of knowledge based upon numerous audits, QMS gap assessment and risk mitigation programs in can help you address the quality, regulatory, and compliance needs of your product and organization at all stages of product development and commercialization. We provide global regulatory consulting and CMC strategies, planning and project management as well as development and review of CMC regulatory filings from Phase I INDs through License SubmissionsCCI offers hands-on, outsourcing, and/or consulting quality assurance services to domestic and international clients. Our industry experienced team members have developed and implemented quality systems within the biopharmaceutical, pharmaceutical, medical device, and combination product industries. We can assist you with organizational activities, plans, policies, procedures, and processes.
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