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Clinical Regulatory Support Services In Usa
59 services found
by:Intertox, Inc. based inSeattle, WASHINGTON (USA)
Strategic Planning – Develop approval strategies including Chemistry Manufacturing and Controls (CMC) and non-clinical and clinical programs. FDA Liaison – Provide guidance and/or serve as a direct liaison with the FDA for the coordination of Prescription Drug User Fee Act meetings. Non-clinical Regulatory ...
Manufactured by:Engenious Design based inPrairie Village, KANSAS (USA)
Labeling, packaging, instructions for use, clinical education and support materials, identity and exhibit graphics ...
Manufactured by:Positron Corporation based inNiagara Falls, NEW YORK (USA)
Positron offers world-class customer service and preventative maintenance program, which supports the Attrius PET system. Positron has been providing world-class customer service and preventative maintenance to our customers for over 20 years. Positron will vigilantly guide you through the entire process of purchasing, site layout, installation, and training. Positron provides on-going clinical ...
Manufactured by:Restorative Therapies, Inc based inBaltimore,, MARYLAND (USA)
At Restorative Therapies, we have an internal licensed clinical support team with decades of experience in physical therapy, occupational therapy, and neurorehabilitation. Our internal clinical support team stands by to provide clinicians and home users with support ...
by:Perform Practice Solutions based inLas Vegas, NEVADA (USA)
We think your front desk team should spend their time welcoming patients, answering the phone, and filling your schedule. But how can they do this when it takes them 45 minutes for each patient’s insurance verification? That’s where we come in… Our team of patient eligibility verification experts wait on hold, get the best PT specific verification info, and send it ...
Manufactured by:Mevion Medical Systems based inLittleton, MASSACHUSETTS (USA)
Once the system is clinical, we provide ongoing support services. Mevion’s maintenance and support services are designed to maximize clinical use and minimize downtime. Because the system design is similar to that of a linear accelerator, Mevion only requires maintenance and support on a quarterly and annual schedule, and can deliver 24/7 beam availability for clinical or research ...
Manufactured by:Hill-Rom Holdings, Inc. based inChicago, ILLINOIS (USA)
Our clinical and technical experts support you with comprehensive services—so you can focus on your patients. The technology you choose for your hospital should seamlessly connect you to your fellow caregivers and your patients. The Hillrom Care Communications Services team works onsite and remotely to build dependable solutions that help you optimize your workflows and maximize your ...
Manufactured by:Integer Holdings Corporation based inPlano, TENNESSEE (USA)
To get your project at fastest time to market, while still complying to the ever changing regulatory environment, we offer you a dedicated and experienced team of project management, material, process and quality engineers, with dedicated cleanroom ...
by:Pennhealth Informatics LLC based inTrevose, PENNSYLVANIA (USA)
PennHealth offers a diverse range of medical transcription services, from Orthodox transcription to platform based online transcription to the Electronic Health Records (EHR). Our transcription offerings support hospitals, clinics, and physicians in the U.S. and other European ...
by:Intrinsik Inc. based inMississauga, ONTARIO (CANADA)
Interaction with regulatory authorities on behalf of clients; Paper and Electronic applications to support; Clinical trials; Marketing applications; and, Post approval and lifecycle management; Support for regulatory consultation meetings; Regulatory strategy; Identifying opportunities for ...
Manufactured by:ClearPoint Neuro, Inc. based inIrvine, CALIFORNIA (USA)
Neurosurgical & Infusion Consultation. Study Design & Protocol Generation. Dedicated On-Site Pre-Clinical Support. Case Reporting & Post-Infusion Analysis. Safety & Toxicology Studies. GLP & Non-GLP Studies. Compatibility Testing. Quality & Regulatory ...
Manufactured by:Sanesco Health based inArden, NORTH CAROLINA (USA)
Belonging to the Sanesco Provider Network means you and your patient are fully supported. Our knowledgeable Clinical Support team is here to guide you every step of the way. These specially trained individuals and clinicians are experts in the interpretation and intervention methods associated with neurotransmitter and hormone ...
by:Doris Duke Charitable Foundation (DDCF) based inNew York, NEW YORK (USA)
Doris Duke was a significant supporter of medical research, making contributions to hospitals and research centers throughout her life. In her will, she expressed her interest in supporting “medical research designed to effectuate cures of major diseases.” ...
Manufactured by:Elpiscience based inShanghai, CHINA
Elpiscience has assembled a global clinical team with a broad range of expertise from designing and leading first-in-human studies to executing large-scale global registration ...
Manufactured by:Innovative Health LLC based inScottsdale, ARIZONA (USA)
Reprocessing does not yield massive savings for an EP lab or a hospital simply because it is contracted with a reprocessor. The reprocessing program must be carefully planned and continuously managed. Its success depends on three things: That all devices that can be reprocessed are included in the program; that devices are carefully and diligently collected; and that whenever a reprocessed device ...
by:Quest Diagnostics based inSecaucus, NEW JERSEY (USA)
Get the clinical decision support your organization needs. Our staff of medical and scientific experts are ready to provide support and share key information to help keep you up-to-date, and quickly connect you to the resources you need—including 600+ MDs and PhDs, and 40+ Genetic Counselors. ...
Manufactured by:Resolution Medical based inFridley, MINNESOTA (USA)
Class I, II, III products from idea/concept through commercialization. Solid Modeling and Prototyping. Extensive 3D Printing. Bench model development & testing. Pre-clinical study support. Engineering Feasibility Studies. Design and Development. Test Method Development & Validation. Design Verification Testing. Design Validation Testing. Process ...
Manufactured by:ARMI - Advanced Regenerative Manufacturing Institute based inManchester, NEW HAMPSHIRE (USA)
We offer regulatory consulting services to support our member organizations with preclinical study design, FDA submissions and interactions and clinical trial design to support existing industries and grow new ones. ...
Manufactured by:Thermo Fisher Scientific based inWaltham, MASSACHUSETTS (USA)
The Oncomine Clinical Research Grant Program supports investigator-initiated studies (IIS) and education projects, on molecular profiling in oncology, with the goal to increase high quality molecular profiling and to help democratize the future of precision medicine. Proposal reviews are conducted by independent and internationally recognized experts together with Thermo Fisher Scientific medical ...
Manufactured by:BrainScope Company, Inc. based inBethesda, MARYLAND (USA)
Advanced digital signal processing of EEG data at the core of FDA cleared A.I., machine learning derived algorithms, empower clinicians to rule out likelihood of brain bleed & objectively assess for ...