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@vistaar2020editor·Vistaar.ai: Regulatory & Clinical Intelligence
Vistaar.ai provides regulatory and clinical intelligence derived from data, assisting individuals and companies in accelerating medicine delivery to patients.
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@vistaar2020editor·
Global Regulatory Publishing and eCTD Submission Services
Makrocare Regulatory Publishing & eCTD Submission Services help you to reduce the cost and effort involved in converting paper-based documentation into eCTD. Submission Services are designed to facilitate advanced publishing activities and to…
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@vistaar2020editor·
Global Regulatory CMC consulting Services
Regulatory CMC consulting services provide regulatory strategy for authoring, preparation, publication and submission of eCTD submission applications for Pharma & life sciences.
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@vistaar2020editor·
Clinical Evaluation Performance (CEP) Report by MakroCare
MakroCare offers a strategy for your clinical evaluation report (CER), including clinical, safety, risk management, and literature data for clinical evaluation performance.
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@vistaar2020editor·
In-vitro Diagnostic Regulation (IVDR) Services
MakroCare experts guide you on how to systematically review your technical documentation and QMS ahead of GAP assessments for EU In Vitro Diagnostic Regulation (IVDR) implementation debates.
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@vistaar2020editor·
Post Market Surveillance (PMS) for Medical Devices
Makrocare offers expertise in post-market surveillance (PMS) to meet medical device market regulations and maintain compliance.
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@vistaar2020editor·
Medical Device Usability Testing Services
Makrocare provides human factors validation testing for medical devices, including formative and summative usability evaluations to support pre-market FDA submissions.
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@vistaar2020editor·
Biocompatibility and Biological Evaluation Reports
MakroCare's teams perform Biocompatibility advisory and Biological Evaluation Reports writing activities, including E&L projects, leveraging pre-clinical, toxicology, biomedical, and chemistry expertise.
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@vistaar2020editor·
Clinical Evaluation Reports (CER) for Medical Devices
Makrocare provides Clinical Evaluation Reports (CER) compliant with Revision 4 and the European Medical Device Regulation (MDR 2017/745).
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@vistaar2020editor·
Clinical Trial Project Management Services
MakroCare provides clinical investigation services for new device IDE studies in various therapeutic areas, including clinical study project & regulatory compliance management.
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@vistaar2020editor·
Regulatory Affairs Consulting Services
MakroCare provides regulatory affairs consulting services and offers regulatory strategy services across product development, registration, and commercialization for medical devices.
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@vistaar2020editor·
Medical Device Surveillance System in Spain
AEMPS has provided all the Medical Device regulatory submission requirements related to safety guidelines that are necessary to apply for Medical Device surveillance system
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@vistaar2020editor·
Drug Label Tracking in Production Distribution
This article discusses drug label tracking to guide safe and effective use with product details such as disease indications, interactions, and adverse reactions.
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@vistaar2020editor·