NCBiotech Company Directory

A comprehensive listing of North Carolina's life science industry

Mapping large numbers of results may take a few moments.

Search Results

Showing 1 - 50 of 53 results found.

Activity Company Description Location
Company ADS Pharma Consulting LLC Activity: Support and Related Support and Related Company Description ADS provides drug development consulting services, including active pharmaceutical ingredient route development and manufacturing, analytics, formulation development, clinical batch manufacture and CMC regulatory affairs. Location Apex
Company akta Pharmaceutical Development LLC Activity: Support and Related Support and Related Company Description aktaPD is a business consortium that provides preclinical and clinical development, medical and regulatory affairs, medical writing and other CRO services to facilitate the design, development and commercialization of treatments for diseases. Location Raleigh
Company Amanda Grim's GCP Audits LLC Activity: Support and Related Support and Related Company Description Amanda Grim's GCP Audits provides clinical QA consulting and auditing services related to risk-based quality strategies, audits, training, SOP development and gap analyses. Location Carolina Beach
Company Anixis Biomedical Consulting LLC Activity: Support and Related Support and Related Company Description Anixis offers business, regulatory and drug development consulting services. Expertise includes business plan and technology assessment, preclinical and clinical drug development, clinical trial protocols, regulatory interactions and writing. Location Durham
Company Apex Biostatistics Inc. Activity: Support and Related Support and Related Company Description Apex Biostatistics provides biostatistics, SAS programming, data management, data modeling and data analysis services to the pharmaceutical industry. Location New Hill
Company ApoGee Clinical Research Consulting LLC Activity: Support and Related Support and Related Company Description ApoGee Clinical Research Consulting provides expertise in strategy, design and implementing clinical programs leading to regulatory submission and commercialization in the biopharmaceutical industry. Location Raleigh
Company Ashfield Pharmacovigilance Inc. Activity: Support and Related Support and Related Company Description Ashfield Pharmacovigilance focuses on drug safety by providing a variety of services, including case management, regulatory consulting, quality management, and a validated safety database. Location Cary
Company Biologics Consulting Group Inc. Activity: Support and Related Support and Related Company Description Biologics Consulting Group provides advice on the development and production of biologics, drugs and medical devices from preclinical through commercial operations. Location Cary
Company BioMed Healthcare Solutions LLC Activity: Support and Related Support and Related Company Description BioMed Healthcare Solutions provides consulting services in the areas of drug safety, medical writing, regulatory affairs and clinical operations. Location Durham
Company Blue Water Technical Services LLC Activity: Support and Related Support and Related Company Description Blue Water Technical Services provides contract validation, quality assurance, compliance and auditing (GMP and GLP) services to the FDA regulated industries (pharmaceutical, medical device, biotechnology, clinical trials, food processing, etc.). Location Farmville
Company Carolina Research Group Inc. Activity: Support and Related Support and Related Company Description Carolina Research group provides services in regulatory affairs, clinical research and general product development. Location Raleigh
Company Certara Activity: Support and Related Support and Related Company Description Certara provides modeling and simulation, regulatory science, and scientific value assessment software and services to aid in drug development. Location Raleigh
Company Cisys LifeSciences Inc. Activity: Support and Related Support and Related Company Description CISYS LifeSciences provided clinical research Software as a Service (SaaS) solutions, technology consulting and software development to the pharmaceutical and biotech community. Location Raleigh
Company Clinfinity LLC Activity: Support and Related Support and Related Company Description Clinfinity provides biostatistical support and programming for clinical research study development. Location Raleigh
Company Clinical Pathways Inc. Activity: Support and Related Support and Related Company Description Clinical Pathways provides consulting services to medical device and in vitro diagnostic product manufacturers with U.S. and international regulatory, clinical, technical, and quality system requirements. Location Raleigh
Company Clinical Pharma Specialist Consultants LLC Activity: Support and Related Support and Related Company Description Clinical Pharma Specialist Consultants provide consulting advice for clinical trial design, pharmaceutical development, safety monitoring and regulatory approaches, with a specialization in the respiratory therapeutic areas. Location Raleigh
Company Clinical QA International LLC Activity: Support and Related Support and Related Company Description Clinical QA International provides clinical research compliance consulting services, including SOP writing, investigator site audits, document and data audits, vendor audits and regulatory inspection readiness for both sponsors and research sites. Location Thomasville
Company Clinical Quality First LLC Activity: Support and Related Support and Related Company Description Clinical Quality First provides compliance consultations in support of clinical trials, specializing in organizational inspection-readiness, setting up Quality Management Systems and independent Clinical Audits. Location Raleigh
Company Clinical Strategies & Tactics Inc. Activity: Support and Related Support and Related Company Description CSTI provides development management services to life sciences companies. Services include identifying cost-effective strategies, defining gaps and leading virtual technical teams to advance asset development to meet business and regulatory milestones. Location Research Triangle Park
Company Coastal Pharmaceutical Consultants Inc. Activity: Support and Related Support and Related Company Description Coastal Pharmaceutical Consultants provides regulatory and quality consulting services, including assistance with product development regulatory strategies, consulting on GMP and GCP issues, and audits and assessment of QC and QA functions. Location Burgaw
Company Cobalt United LLC Activity: Support and Related Support and Related Company Description Cobalt United provides clinical and regulatory services to aid pharmaceutical development in a broad range of therapeutic areas. Cobalt United also sells personal protective equipment. Location Raleigh
Company Copernicus Group IRB Activity: Support and Related Support and Related Company Description Copernicus Group is a third party reviewer of study plans for drug development companies, as mandated by the FDA. Their primary focus is ensuring the rights and welfare of human research subjects by assuring regulatory compliance. Location Cary
Company Cornerstone Pharma Consulting LLC Activity: Support and Related Support and Related Company Description Cornerstone Pharma Consulting provides formulation development, clinical trial supplies manufacturing and packaging, process optimization, formulation/process trouble shooting and scale-up consulting services. Location Raleigh
Company CTI Clinical Trial and Consulting Services Activity: Support and Related Support and Related Company Description CTI Clinical Trial and Consulting Services is a full-service contract research organization that delivers clinical trial and consulting services throughout the lifecycle of drug development. Location Raleigh
Company D.P. Ward, MD, Drug Development Consulting Inc. Activity: Support and Related Support and Related Company Description D.P. Ward, MD, Drug Development Consulting provides Phase I-III drug development and regulatory consulting and due diligence. Location High Point
Company Drug Safety Navigator LLC Activity: Support and Related Support and Related Company Description Drug Safety Navigator provides safety and pharmacovigilance consulting to small to mid-sized pharmaceutical and biotech companies. Services include adverse event case management, benefit-risk assessment, PV training, medical writing and signal detection. Location Durham
Company Eolus Compliance Solutions Activity: Support and Related Support and Related Company Description Eolus provides systems and regulatory compliance consulting and auditing, including quality by design, QMS. data integrity and privacy, gap analysis, design controls, software lifecycle and risk analysis for GXP life science industries. Location Raleigh
Company Evidera Inc. Activity: Support and Related Support and Related Company Description Evidera, a business of PPD, provides evidence-based solutions to demonstrate the real-world effectiveness, safety, and value of biopharmaceutical and biotechnology products. Location Morrisville
Company FDA Quality and Regulatory Consultants LLC Activity: Support and Related Support and Related Company Description FDA Quality and Regulatory Consultants offers specialized quality, regulatory and validation consulting for pharmaceutical, medical device and biotech companies. Location Raleigh
Company Inpernum Pharma Solutions LLC Activity: Support and Related Support and Related Company Description Inpernum provides strategic biopharmaceutical support across pre-IND activities, regulatory filings, communications and submissions, clinical development strategies, and CMC/Quality activities for emerging biopharma companies. Location Raleigh
Company Lapp MW Group Activity: Support and Related Support and Related Company Description Lapp MW Group provides regulatory medical writing and medical communication services, including CSRs, protocols, and IBs, as well as higher-level submission documents, such as, ISEs, SCEs, and module 2.5. Location Hillsborough
Company LMK Clinical Research Consulting LLC Activity: Support and Related Support and Related Company Description LMK Clinical Research Consulting provides document management services for pharmaceutical and biotechnology companies and clinical trial sites. Location Huntersville
Company MSS Pharmaceutical Consulting Inc. Activity: Support and Related Support and Related Company Description MSS Pharmaceutical Consulting provides consulting services to biotechnology companies and CROs on quality assurance, clinical monitoring, site compliance and staff assessments. Location Leland
Company Myer PharmTox Consulting LLC Activity: Support and Related Support and Related Company Description Myer PharmTox Consulting offers nonclinical toxicological consulting to pharma clients. Services include nonclinical development plan formulation, CRO laboratory selection, site monitoring, data analysis and communication with regulatory agencies. Location Cary
Company Nuventra Pharma Sciences Inc. Activity: Support and Related Support and Related Company Description Nuventra Pharma Sciences is a clinical pharmacology consulting firm specializing in pharmacokinetics and pharmacometrics. Nuventra also provides regulatory, writing and strategy support for nonclinical and clinical development plans. Location Research Triangle Park
Company OD Consulting and Neurological Services PLLC Activity: Support and Related 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
Company Ofni Systems Activity: Support and Related Support and Related Company Description Ofni Systems provides electronic data management (EDM) software, consulting and training to FDA regulated industries, including pharmaceuticals, bioscience, medical devices and clinical trials. Location Raleigh
Company OrthoKinetic Technologies LLC Activity: Support and Related Support and Related Company Description OrthoKinetic Technologies is a medical device testing and regulatory consulting firm with a subsidiary ISO certified test facility. The company provides a turnkey approach for assessing medical device performance and safety. Location Southport
Company Pivot Oncology LLC Activity: Support and Related 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
Company Polaris Compliance Consultants Inc. Activity: Support and Related Support and Related Company Description Polaris Compliance Consultants Inc. is a compliance consulting company specializing in auditing, training and writing in all areas of GCP, GMP, GLP and Part 11 compliance for the pharmaceutical, dietary supplement and medical device industries. Location Cary
Company PrimeVigilance USA Inc. Activity: Support and Related Support and Related Company Description PrimeVigilance USA offers drug life cycle management services. Services include pharmacovigilance, pharmacoepidemiology and benefit risk-management, audit and inspection, and regulatory science. Location Cary
Company ProMedoss Inc. Activity: Support and Related Support and Related Company Description ProMedoss supports medical device startups and entrepreneurs in bringing medical devices to market. Services include support in regulatory compliance, clinical trials, quality management systems, risk management, due diligence and reimbursements. Location Charlotte
Company Reg-Tec Inc. Activity: Support and Related Support and Related Company Description Reg-Tec provides regulatory consulting and clinical management services to pharmaceutical companies that require assistance in the development of branded and generic products. Location Wilmington
Company Regulatory Writing Solutions LLC Activity: Support and Related Support and Related Company Description Regulatory Writing Solutions provides professional regulatory medical writing and consulting services to the pharmaceutical, biotechnology and CRO industries. Location Wilmington
Company Rothermel Clinical Research Consulting LLC Activity: Support and Related Support and Related Company Description Rothermel Clinical Research Consulting provides contract medical writing and consulting, specializing in oncology clinical research. Location Sunset Beach
Company SEC Associates Inc. Activity: Support and Related Support and Related Company Description SEC Associates provides the International Clinical Trial Disclosure Knowledge Base, an online resource for transparency requirements including public registration and results disclosure laws, regulations and required data sets. Location Raleigh
Company SFP Consulting LLC Activity: Support and Related 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
Company Social & Scientific Systems Inc. Activity: Support and Related Support and Related Company Description Social & Scientific Systems provides technical biomedical research and IT support, project and program management services in the areas of clinical, epidemiologic, and public health studies, health data management, program evaluation and policy analysis. Location Durham
Company Statogen Consulting Activity: Support and Related Support and Related Company Description Statogen Consulting is a biostatistics consulting company specializing in advanced pharmaceutical design and analysis of clinical trials. Location Wake Forest
Company Triangle Clinical Research International LLC Activity: Support and Related Support and Related Company Description Triangle Clinical Research International is a clinical research advisory and management company, focused on optimizing clinical research at academic and medical research centers. Location Cary