Companies similar to FDA CONSULTING
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  • www.fda510kconsultant.com
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FDA Consulting LLC specializes in regulatory and compliance related submission services to manufacturers, importers, and suppliers of medical devices. Our FDA Consultants are experts in medical device 510(k) submission to FDA for product approval...
Relevance: 34.375175
  • www.heconsultingllc.com
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HE Consulting brings together designers, engineers, regulatory affairs, and quality assurance to produce safe, easy to use, and effective medical devices. We design and conduct activities to ensure the human element is considered at all stages of the..
Relevance: 28.798712
  • www.b-savvybiomedical.com
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At bSavvy BioMedical we are serious about getting to know you. Every client is special to us and we know how to listen... Home page. We offer consulting in mDx, molecular diagnostics, research, IVDs, LDTs, ASRs, FDA 510(k) submission medical..
Relevance: 27.95006
  • fdaconsultants.com
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It is just as important for Smith Associates, as it is for you, to determine if we are the right consulting firm to assist you through the FDA clearance process. Smith Associates provides FREE product classification, product code and quality system..
Relevance: 27.532223
  • www.irisstatcomp.com
Iris is a consulting firm that serves biotech and pharmaceutical companies. Our expertise is in ensuring quality and timely FDA data submission filings for New Drug Applications (NDAs) and Biologics License Applications (BLAs). With our proprietary..
Relevance: 24.342564
  • www.matrixmedicaldevices.com
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From project management and regulatory submission, to post-market surveillance and remediation, Matrix Medical Devices is your regulatory and quality partner... Matrix Medical Devices provides the regulatory and quality expertise to navigate US FDA..
Relevance: 23.966503
  • smstesting.com
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Founded in 1994, Select Medical Systems, inc. (SMS), submitted its first 510K submission to the Food and Drug Administration (FDA) for an analyzer approval... Additionally, SMS offers complete and custom designed data management software, as well as..
Relevance: 23.638798
  • www.improvementatwork.nl
Improvement at Work is a consulting firm which supports biotech and pharmaceutical companies in their first NDA/MAA to FDA/EMA or other agencies. Our submission experts work as part of an integrated team with internal regulatory and project..
Relevance: 23.49464
  • www.advenausa.com
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Our goal is to provide cost- effective, efficient medical device regulatory affairs consulting services that are tailored to meet the unique needs of our customers... At Advena USA we understand how complex regulatory compliance requirements can be...
Relevance: 23.254318
  • www.sagesubmissions.com
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Sage Submissions is dedicated to helping you streamline the process for creating submissions for drug, biologic and medical devices. Sage Templates™, a MS Word-based tool, helps you create documents that support the global electronic Common Technical..
Relevance: 23.249125
  • lazzaromed.com
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CAUTION: LM Scaffold System™, LM DL Tube™ and LM Scope™ are not cleared or approved products by regulatory bodies in the US or internationally and are pending FDA submission. LM Scaffold System™ , LM DL Tube™ and LM Scope™ are registered trademarks..
Relevance: 23.092817
  • podshealth.com
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Pods Health is an international healthcare supplies organization that provides seamless access and inventory of medical equipment and personal protective equipment to hospitals, governments, medical institutions, and foundations all across the..
Relevance: 22.45491
  • www.qnrassociates.com
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QnR Associates is a Regulatory and Quality Assurance consulting company distinguished by its reputation for high quality and reliable service to meet the client's needs with Health Canada and FDA market authorization submission requirements and GMP..
Relevance: 22.417679
  • www.q2bi.com
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Q2BI team has experience supporting over 900 studies and 27 successful NDA/BLA submission approvals (FDA, EMA, PMDA and NMPA) in various therapeutic areas. Q2BI is a pioneer in adopting CDISC and supported the world first FDA Project ORBIS... We..
Relevance: 22.227757
  • medicaldeviceregulatoryconsulting.com
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The technical experts at your company have worked hard to develop a product to meet a need in the healthcare market. Working as your partner, our team translates their work product into a regulatory submission that will meet requirements specified by..
Relevance: 22.196602
  • loriacarrinc.com
President and CEO of Lori A. Carr, Inc., is a Principle Consultant in the Medical Device regulated industry... Lori A Carr, qualified FDA regulatory professional consulting with previous FDA medical device experience...
Relevance: 22.06203
  • xfdainvestigators.com
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We are a group of former FDA Investigators and Compliance Officers working to bring effective, quality solutions to your firm... As a pharmaceutical industry consulting company, our mission is to help your firm build effective, successful and..
Relevance: 22.047792
  • improvementatwork.com
IS YOUR ORGANIZATION PREPARING FOR ITS FIRST SUBMISSION? NO DOUBT YOU HAVE THE BUILDING BLOCKS IN PLACE FOR SUCCESS. NOW IT'S TIME TO WORK ON THE DETAILS THAT WILL ENABLE THE FASTEST TIME TO MARKET... Improvement at Work is a consulting firm which..
Relevance: 21.920393
  • www.oneregulatory.com
OneRA delivers rapid, positive responses from the FDA and global regulatory authorities whether it be related to a submission, audit and inspection observations, quality systems or the day-to-day activities of most medical device companies. Whatever..
Relevance: 21.913507
  • www.hoyregulatory.com
Hoy & Associates was founded by Connie Hoy after her retirement in 2018. Having worked in industry for 33 years, Connie is well versed in the day to day challenges of developing strategies and obtaining approvals , developing and maintaining quality..
Relevance: 21.864038
  • pathsurveyor.com
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PathSurveyor is a free service provided by in2being, LLC to help anyone get a head start on finding the best regulatory path for their device... With FDA clearance times taking 3 months or more and submission lengths expanding beyond 1000 pages 1,..
Relevance: 21.547152
  • www.oxdevice.com
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At OxDevice we are passionate about designing, developing, and manufacturing medical devices. We support companies to achieve their goals in launching a new product or concept through a unique product design and development process... OxDevice..
Relevance: 21.483786
  • www.fda-pharmacovigilance.com
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515 Consulting Group provides expert advice and systems integration products and services to Pharmaceutical, Biotech and Medical Device companies and third-party service companies such as CROs. We focus on Regulatory Activities necessary to gain drug..
Relevance: 21.366896
  • www.omniscience-ltd.com
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OmniScience was established in 2009 as an independent contract service organization providing scientific and medical writing services to the pharmaceutical industry, biotechnology companies, and academia... Based in Geneva, Switzerland, in the..
Relevance: 21.244867
  • www.ecsor.com
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ECSOR offers personalized services in Medical Writing, Data Management, Electronic Data Capture (EDC), Clinical Monitoring, Investigator's Network, Submission to EC & CA, Regulatory affairs (FDA, EMEA) and Safety... Key to the success of a project..
Relevance: 21.1206
  • www.cayugaconsult.com
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Cayuga Consulting is a full-service Medical Writing and Clinical Research Consulting firm. Headquartered in Providence, RI, Cayuga Consulting provides contract medical writing, clinical development support, and regulatory submission services to the..
Relevance: 21.085094
  • www.oconnellregulatory.com
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O'CONNELL REGULATORY CONSULTANTS, INC. is a consulting practice which specializes in medical device regulatory affairs and clinical study management, focusing on obtaining FDA marketing approval for medical devices and combination drug/device..
Relevance: 21.003002
  • www.515-consulting.com
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515 Consulting Group was founded by Lee Knoch, M.E. to assist the Life Sciences industry with the complexities of choosing and integrating Regulatory solutions. Prior to founding 515 Consulting Group, Mr. Knoch was the President and CEO of the North..
Relevance: 20.908895
  • en.hsmedt.com
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Shanghai Harborside Medical Technology Co., Ltd. (Harborside), formerly a laboratory founded by NAMSA in Shanghai in 2016, is a pre-clinical animal laboratory operating in compliance with FDA GLP Regulations. As an industry-leading and the first..
Relevance: 20.868637
  • katomed.ai
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Katomed's automation platform eliminates the gap between surgical intent and execution, with FDA submission-ready technology that transforms what's possible in the operating room...
Relevance: 20.698761