Consulting, Regulatory

NCBiotech Company Directory is a comprehensive listing of North Carolina's life science industry New search

Company Title Company Description City
Kapstone Medical Logo Kapstone Medical LLC

Kapstone is a single-source service provider to medical device companies lacking the appropriate human capital to commercialize new products. Kapstone also supports inventors who need assistance assessing, designing and monetizing their inventions.


Kymanox offers project delivery expertise to clients in the biologics, pharmaceutical, medical device, and combination product industries. Services include engineering, scientific, quality and regulatory support.

LMK Clinical Research Consulting LLC

LMK Clinical Research Consulting provides document management for pharmaceutical and biotechnology companies and clinical trial sites.

Mispro Biotech Services Corp.

Mispro Biotech Services offers biopharmaceutical and life sciences companies access to a vivarium research facility that includes comprehensive laboratory animal sciences services supporting early-stage drug development.

Research Triangle Park
Nuventra Pharma Sciences Inc.

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.

Research Triangle Park
Sequence Inc.

Sequence Inc. provides engineering, commissioning, validation, regulatory compliance, logistics and facility monitoring, laboratory compliance and data analytics services for clients in the life sciences industry.

Verta Life Sciences LLC

Verta Life Sciences provides consulting services to pharmaceutical, biotech and medical device companies in areas such as product development, quality and regulatory compliance, manufacturing, marketing and supply chain management.

3D Communications

3D Communications provides strategic regulatory and value communications services to pharmaceutical, device and biologic companies. Services include messaging, scripting, slide development and communications coaching.

Abaci Analytical LLC

Abaci Analytical offers consulting in health care, academic, government, clinical and pharmaceutical manufacturing spaces. Abaci specializes in CSV validation and implementation of computer systems, biorepository management and laboratory buildout.

Southern Pines
Accelerated BioPharm LLC

Accelerated BioPharm provides development services for generic, new drug, device and supplement products. Services include regulatory consulting, technical writing and document management, and vendor and site auditing and management.

AcceleReg LLC

AcceleReg provides general regulatory and submission support and GXP compliance consulting to pharmaceutical companies in various stages of development. AcceleReg also interfaces with regulatory authorities on behalf of clients.

Acuity Edge Inc.

Acuity Edge is a management consulting firm that provides strategic-level services for corporate, university, government, and venture capital clients. Acuity Edge assists with product development, market research, intellectual property licensing, etc.

ADS Pharma Consulting LLC

ADS provides drug development consulting services, including active pharmaceutical ingredient route development and manufacturing, analytics, formulation development, clinical batch manufacture and CMC regulatory affairs.

Advanced Barrier Concepts Inc.

Advanced Barrier Concepts provides isolation technology and aseptic manufacturing consulting services to pharmaceutical manufacturers.

Advanced Cell & Gene Therapy LLC

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, regulatory affairs, QA and strategy.

Chapel Hill
ADVENT Engineering Services Inc.

ADVENT Engineering Services is an engineering consulting firm that provides design, process engineering, automation, start up, commissioning/qualification and compliance services to the bio-pharmaceutical industry.

AGodfrey Pharma LLC

AGodfrey Pharma provides regulatory medical writing services, including clinical study reports, clinical protocols, protocol amendments, NDA summary documents, IND summary documents, informed consent forms, and other regulatory documents.

akta Pharmaceutical Development LLC

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.

Alba BioPharm Advisors Inc.

Alba BioPharm Advisors provides consulting services in new drug and technology development, pharmacovigilance, regulatory affairs and new business development.

Align Global Consulting Inc.

Align provides advisory services that help clients expand globally or improve existing operations by providing creative legal and tax solutions to address commercial, trade, investment and regulatory matters.

Alpha-Gamma Technologies Inc.

Alpha-Gamma Technologies provides consulting services and information technology solutions in toxicogenomics, bioinformatics, data mining and warehousing for government, biotechnology and pharmaceutical industries.

AlphaMed Consulting Inc.

AlphaMed Consulting provides strategic support for academic cancer centers and cancer drug development programs for global pharmaceutical and biotechnology companies.

Alta Vetta Pharmaceutical Consulting LLC

Alta Vetta Pharmaceutical Consulting provides discovery, development, CMC and scientific regulatory consulting services for preclinical, clinical and commercial products.

Amanda Grim's GCP Audits LLC

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.

Carolina Beach
American Hemp LLC

American Hemp is a supplier and industry consultant for the hemp crop and other biomaterials.

Amris Consulting LLC

Amris Consulting provides support for biopharmaceutical manufacturers, including CAPA and GMP compliance services and investigations, IT and equipment validation, technical writing and other project support.

Pine Level
Anita O'Connor Consulting LLC

Anita O’Connor Consulting provides regulatory affairs consulting services for the pharmaceutical, medical device, food, and animal drug industry.

Anixis Biomedical Consulting LLC

Anixis offers business, regulatory and drug development advising services. Expertise includes business plan and technology assessment, preclinical and clinical drug development, clinical trial protocols, regulatory interactions and writing.

Anne McKay Inc.

Anne McKay Inc. provides regulatory consulting with eperience from pre-IND through post marketing with drugs and biologicals in many therapeutic areas.

Apex Biostatistics Inc.

Apex Biostatistics provides biostatistics, SAS programming, data management, data modeling and data analysis services to the pharmaceutical industry.

New Hill
ApoGee Clinical Research Consulting LLC

ApoGee Clinical Research Consulting provides expertise in strategy, design and implementing clinical programs leading to regulatory submission and commercialization in the biopharmaceutical industry.

Applied Biopharmaceutics LLC

Applied Biopharmaceutics is a pharmaceutical consultant group with expertise in biopharmaceutics, pharmacokinetics and bioavailability. The company helps clients develop new dosage forms for ANDA and NDA submissions, and provides expert legal testimony.

Applied Calibration Services

Applied Calibration Services provides on-site facility, process and analytical calibrations, as well as training and staff augmentation.

Applied Pharma Solutions NC LLC

Applied Pharma Solutions provides biotech and pharmaceutical consulting, specializing in quality assurance, compliance and validation.

Arbour Group LLC

Arbour Group provides regulatory compliance products and services for the life sciences industry across the supply chain. Arbour Group specializes in enterprise software testing for data center, infrastructure and application layers.

Research Triangle Park
Ascent Pharma Consulting LLC

Ascent provides consulting services in pharmaceutical development from candidate selection through commercial launch including formulation and process development, clinical trial materials, regulatory plan, project management and supply chain management.

Wake Forest
Aseptic Haven LLC

Aseptic Haven provides life sciences consulting in aseptic technique and gowning training, cleanroom behaviors, deviation investigations and ISO area qualification testing and reporting, as well as workforce development and diversity management.

Ashfield Pharmacovigilance Inc.

Ashfield Pharmacovigilance focuses on drug safety by providing a variety of services, including case management, regulatory consulting, quality management, and a validated safety database.

Avid Solutions Inc. (Morrisville)

Avid Solutions provides industrial process controls, instrumentation and validation services.

Baird Regulatory Services LLC

Baird Regulatory Services provides drug regulatory affairs consulting.

Bio Business Consultants LLC

Bio Business Consultants provides business development, regulatory and R&D consulting services.

Biobanking Without Borders LLC

Biobanking Without Borders provides scientific, financial and regulatory consulting for biorepositories.

Biologics Consulting Group Inc.

Biologics Consulting Group provides advice on the development and production of biologics, drugs and medical devices from preclinical through commercial operations.

BioMed Healthcare Solutions LLC

BioMed Healthcare Solutions provides consulting services in the areas of drug safety, medical writing, regulatory affairs and clinical operations.

BioTechLogic Inc.

BioTechLogic is a CMC consulting firm that helps clients bring their products to market by augmenting an organization's technical, manufacturing, analytical, and regulatory resources.

Biotechnology Consulting Services LLC

Biotechnology Consulting Services provides regulatory and product development consulting services to the agricultural biotechnology community.

Chapel Hill
BioTechnology Transfer LLC

BioTechnology Transfer provides services to life science companies, including regulatory assessments, GLP/cGMP/ISO quality systems, document control, FDA submissions, CE marking assistance, design control, project management and product development.

Biothermal LLC

Biothermal provides commissioning and qualification services in the pharma/biotech industry and manufactures defect kits for the qualification of automated and manual inspection of parenteral products. Biothermal can fill non-sterile product in vials.

Blue Cedar CMC Pharma Solutions LLC

Blue Cedar CMC Pharma Solutions provides consulting services with expertise in CMC analytical deliverables and global product registration.

Blue Ridge Food Ventures LLC

Blue Ridge Food Ventures is a shared-use food and natural product processing facility that offers support in product development, regulatory guidance, and advice on packaging and label design.

Blue Water Technical Services LLC

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.).

Bluewater Technology Partners LLC

Bluewater Technology Partners provides information technologies and computer system validation supporting life science, pharmaceutical, biotechnology and bioanalytical firms as well as general information technology initiatives.

Bozenhardt Consulting Services LLC

Bozenhardt Consulting Services provides technical consulting to pharmaceutical, biotechnology and medical device manufacturing companies. BCS specializes in aseptic filling, biological manufacturing, facilities design, compliance, audits and training.

Cabernet Pharmaceuticals Inc.

Cabernet Pharmaceuticals is a pharmaceutical regulatory consulting company.

Chapel Hill

CAI provides technical services for regulated environments, including commissioning and qualification, asset management, quality and regulatory compliance, automation and information technology, and process and manufacturing technology.

CARGOpak Corp.

CARGOpak provides on-site employee training and consulting expertise for safe transport of hazardous materials, including biological and infectious materials. The company assists with regulatory compliance for both domestic and international shipping.

Wake Forest
Carolina Research Group Inc.

Carolina Research group provides services in regulatory affairs, clinical research and general product development.

Carringers Inc.

Carringers is a research management organization that performs field studies related to crop protection.

Cato BioVentures

Cato BioVentures, the venture capital affiliate of Cato Research Ltd., invests in opportunities at all stages of development and across multiple therapeutic areas in private and public companies.


Certara provides modeling and simulation, regulatory science, and scientific value assessment software and services to aid in drug development.

Chymesis LLC

Chymesis provides CMC consulting services. Expertise includes drug development, CMC regulatory support, due diligence and commercial manufacturing and compliance support.

Cisys LifeSciences Inc.

CISYS LifeSciences develops technology and software solutions for the research, pharmaceutical, biotech and healthcare industries. They specialize in clinical, compliance and commercial solutions and services, specifically EDC for clinical trials.

Clarkston Consulting

Clarkston Consulting provides strategy, innovation, M&A advisory, sales and marketing, supply chain, regulatory, clinical R&D and technology consulting services to life science companies.

Class Three LLC

Class Three provides regulatory consulting services to early phase medical device startups.

Clinfinity LLC

Clinfinity provides biostatistical support and programming for clinical research study development.

Clinical Pathways Inc.

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.

Clinical Pharma Specialist Consultants LLC

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.

Clinical QA International LLC

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.

Clinical Strategies & Tactics Inc.

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.

Research Triangle Park
Coastal Pharmaceutical Consultants Inc.

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.

Cobalt United LLC

Cobalt United provides clinical and regulatory services to aid pharmaceutical development in a broad range of therapeutic areas.

Code Refinery LLC

Code Refinery provides custom software development, verification, and validation services for medical device manufacturers.

Copernicus Group IRB

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.

Cornerstone Pharma Consulting LLC

Cornerstone Pharma Consulting provides formulation development, clinical trial supplies manufacturing and packaging, process optimization, formulation/process trouble shooting and scale-up consulting services.

Covenant Pharmaceutical Services Inc.

Covenant Pharmaceutical Services provides quality management systems, GMP compliance and validation consulting services for the pharmaceutical, medical device, biologics and biotech industries.

Hope Mills
Cowlen Consulting LLC

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.

Chapel Hill
CRC Clinical Research Services Inc.

CRC Clinical Research Services provides feasibility assessments, audit preparation, regulatory document training, and regulatory document creation, review, submission and site release services.

CTI Clinical Trial and Consulting Services

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.

Cutting Edge Information

Cutting Edge Information provides consulting and research services to life science companies on a wide range of management issues with a focus on helping clients build stronger relationships with physicians, patients, payers and other stakeholders.

Research Triangle Park
CZ Biopharma LLC

CZ Biopharma provides validation and regulatory compliance consulting services.

D.P. Ward, MD, Drug Development Consulting Inc.

D.P. Ward, MD, Drug Development Consulting provides Phase I-III drug development and regulatory consulting and due diligence.

High Point
DCB Pharma Consulting LLC

DCB Pharma Consulting provides quality and laboratory operations consulting for the pharmaceutical and biopharmaceutical industries.

Deloitte LLP

Deloitte provides accounting, auditing, tax and business consulting services.

Dexxis Pharma Consulting PLLC

Dexxis Pharma Consulting provides drug development and drug safety consulting services.

Diversified Compliance Services LLC

Diversified Compliance Services provides validation and consulting services to the pharmaceutical, biotech and clinical research industries.

Double Dragon Consulting Inc.

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.

Chapel Hill
Drug Safety Navigator LLC

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.

Chapel Hill
E. Maygoo Technologies LLC

E. Maygoo Technologies provides project management and consulting services in engineering, IT, compliance and QA, tech transfer, clinical services, as well as biopharma staffing.

Eastern Carolina Food Ventures Incubator Kitchen

Eastern Carolina Food Ventures Incubator Kitchen is a regional, shared-use commercial incubator kitchen designed to help develop food entrepreneurs, create new food businesses, and grow existing food businesses in eastern North Carolina.

Eastwood Pharmaceutical Consulting LLC

EPC provides consulting and product development services for pharmaceuticals, devices, diagnostics and other health technologies. The company's priority is to maximize efficiency of the development process by eliminating unnecessary expense or work.

EI Group Inc.

EI Group is an environmental, health and safety consulting firm.

EJB Pharma Consulting LLC

EJB Pharma Consulting provides services in pharmaceutical and biotech CMC development, API development, formulation development, process development, regulatory, management of CROs and technology evaluation.

Elliott Davis Decosimo LLC

Elliott Davis Decosimo provides assurance services, tax services and consulting services regarding business and strategic planning, mergers and acquisitions, risk management and business valuation.

Encova Consulting Inc.

Encova Consulting is an engineering and consulting company that provides a wide range of services including project management, validation, quality assurance, regulatory, machine design and process optimization.

Eolus Compliance Solutions

Eolus provides GXP and Part 11 quality and compliance consulting services, including data integrity, audits, gap analysis, design controls and risk analysis for the pharmaceutical, medical device and biotechnology industries worldwide.


ERM provides environmental, health, sustainability, safety and risk consulting services in many industry sectors, including the pharmaceutical, chemical and manufacturing industries.

Evidera Inc.

Evidera, a business unit of Pharmaceutical Product Development (PPD), provides evidence-based solutions to demonstrate the real-world effectiveness, safety, and value of biopharmaceutical and biotechnology products.

FDA Consulting LLC

FDA Consulting offers quality management systems, regulatory strategies and submissions for medical devices and in vitro diagnostics.

FDA Quality and Regulatory Consultants LLC

FDA Quality and Regulatory Consultants offers specialized quality, regulatory and validation consulting for pharmaceutical, medical device and biotech companies.

Focus 42 LLC

Focus 42 provides consulting expertise for medical device software development, in vitro diagnostics (IVD), Mobile Medical Applications (MMA) and Software as a Medical Device (SaMD) for FDA/EU/cFDA compliance.