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Showing 1 - 22 of 22 results found.
| Company | Activity | Company Description | Location | |
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Company Advanced Cell & Gene Therapy LLC | Activity: Support and Related | Company Description Advanced Cell & Gene Therapy is a consulting firm specializing in development and commercialization of cell therapy, gene therapy, immunotherapy, and regenerative medicine products. Expertise includes manufacturing (CMC), regulatory affairs, QA and strategy. | Location Chapel Hill |
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Company Blue Cedar CMC Pharma Solutions LLC | Activity: Support and Related | Company Description Blue Cedar CMC Pharma Solutions provides consulting services with expertise in CMC analytical deliverables and global product registration. | Location Hillsborough |
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Company Cowlen Consulting LLC | Activity: Support and Related | Company Description Cowlen Consulting specializes in nonclinical drug development, including safety assessment and regulatory strategy, toxicology study design and program management, regulatory writing, and direct interaction with the FDA. | Location Chapel Hill |
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Company Dexxis Pharma Consulting PLLC | Activity: Support and Related | Company Description Dexxis Pharma Consulting provides drug development and drug safety consulting services. | Location Hillsborough |
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Company Double Dragon Consulting Inc. | Activity: Support and Related | Company Description Double Dragon Consulting offers quality system assessments and development, Warning Letter remediation, pre-inspection and supplier audits, QRM and data integrity training, and project management services to the life science industry. | Location Carrboro |
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Company Formulation Hause LLC | Activity: Support and Related | Company Description Formulation Hause is a consulting company providing formulation consulting services, specializing in product development, technical transfer, clinical manufacture, regulatory support for the CMC section of ANDA, IND, NDA product filings. | Location Carrboro |
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Company Gnomon Group LLC | Activity: Support and Related | Company Description Gnomon Group provides regulatory, clinical, preclinical, chemistry manufacturing controls and project management consulting services for drug development companies. They also provide electronic publishing and FDA ESG submission services. | Location Carrboro |
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Company GxP Compliance Associates LLC | Activity: Support and Related | Company Description GxP Compliance Associates provides strategic GMP, GLP and GCP consulting and auditing services to the pharmaceutical and medical device industries. | Location Chapel Hill |
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Company Integrated CMC Solutions LLC | Activity: Support and Related | Company Description Integrated CMC Solutions provides drug development consulting on preformulation, formulation, manufacturing, packaging, distribution, project management, characterization, analysis and stability, regulatory CMC documentation, compliance and training. | Location Chapel Hill |
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Company Intrinsik | Activity: Support and Related | Company Description Intrinsik is a scientific & regulatory consulting firm providing expert toxicology & regulatory advice. | Location Hillsborough |
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Company JSM Pharmaceutical Consulting LLC | Activity: Support and Related | Company Description JSM Pharmaceutical Consulting provides drug development consulting services for formulation and delivery development, regulatory concerns, process scale-up and training. | Location Mebane |
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Company Meade Biologics LLC | Activity: Support and Related | Company Description Meade Biologics provides consulting services related to the manufacturing, testing and regulation of vaccines and biologics. Areas of specialization include clinical immunoassays, bioassays and potency tests. | Location Hillsborough |
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Company Nerrele Life Sciences | Activity: Support and Related | Company Description Nerrele Life Sciences offers data management, bioinformatics, biostatistics, IT governance support, and GcP/GxP audit services. | Location Hillsborough |
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Company OD Consulting and Neurological Services PLLC | Activity: Support and Related | Company Description OD Consulting and Neurological Services provides consulting in the areas of clinical development, safety monitoring and regulatory submissions of CNS-focused drugs and devices, and healthcare training and clinical services. | Location Chapel Hill |
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Company PedMed Consulting LLC | Activity: Support and Related | Company Description PedMed Consulting offers pediatric medicines regulatory consulting services, with expertise in EU Pediatric Investigation Plans (PIPs), US Pediatric Study Plans (PSPs) , and Proposed Pediatric Study Requests (PPSRs). | Location Chapel Hill |
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Company Pivot Oncology LLC | Activity: Support and Related | Company Description Pivot Oncology provides consulting and development services such as regulatory strategy and program management. The company specializes in first-time-in-human to proof-of-concept oncology clinical trials. | Location Chapel Hill |
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Company Research Solutions Consulting LLC | Activity: Support and Related | Company Description Research Solutions Consulting provides consulting services to bioscience companies in all areas of grant administration (pre- and post-award) for federal and foundation grants/contracts. The company assists small companies with SBIR/STTR grants. | Location Chapel Hill |
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Company SFP Consulting LLC | Activity: Support and Related | Company Description SFP Consulting provides medical writing and regulatory submissions project management services to support development of pharmaceuticals and biologics. The firm also provides training on these topics. | Location Chapel Hill |
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Company The Jans Group LLC | Activity: Support and Related | Company Description The Jans Group provides regulatory affairs and quality assurance consulting to the medical device industry in the areas of product development, regulatory strategy/planning, regulatory submissions (domestic and global), labeling, technical writing, and training. | Location Hillsborough |
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Company Validant | Activity: Support and Related | Company Description Validant provides laboratory research and manufacturing services as well as regulatory and quality consulting and outsourcing solutions. | Location Durham |
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Company Venebio Group LLC | Activity: Support and Related | Company Description Venebio Group provides consulting on a variety of life science topics, including epidemiology, health informatics, personalized/precision healthcare, drug/device development and safety, scientific legal support and health economics and outcomes research. | Location Chapel Hill |
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Company Whitsell Innovations Inc. | Activity: Support and Related | Company Description Whitsell Innovations provides medical and scientific writing services to pharmaceutical, biotech and device companies. WI writes regulatory documents from the preclinical stage through post-marketing needs. | Location Chapel Hill |