Life Sciences Tools and Services
Company Overview of MakroCare Clinical Research Limited
MakroCare Clinical Research Limited operates as a drug development and commercialization partner for pharmaceutical, biotechnology, and medical device industries. The company provides consulting services, including R&D consulting; product globalization; regulatory, risk, and compliance; market access and reimbursement; medical device consulting; information technology; and human resource capital management. It also offers regulatory services, such as regulatory strategy, risk management and mitigation strategies, regulatory submission, regulatory writing, eCTD capabilities, and labeling; and patient enrollment and site management services, including protocol feasibility and country/site sele...
One Washington Park
Newark, NJ 07102
Founded in 1996
Key Executives for MakroCare Clinical Research Limited
Associate Director of Biostatistics
Vice President of Global Services
Associate Director of Global Quality Assurance
Associate Director of Medical Writing Operations
Compensation as of Fiscal Year 2015.
MakroCare Clinical Research Limited Key Developments
MakroCare Launches Vistaar, a Regulatory Intelligence Tool
Jul 28 13
MakroCare announced the addition of Vistaar, a Regulatory Intelligence tool, to it’s RA portfolio. Reg Intel was always the foundation of MakroCare services, with Vistaar, it’s formalized as a tool that it’s customers can benefit from. Vistaar will be part of Regulatory Affairs Center of Excellence (RACoE) that MakroCare formed earlier. Life Sciences customers can now leverage these assets of RACOE to their advantage to gain productivity and knowledge efficiencies. This CoE currently supports Regulatory Operations, Life Cycle support, CMC/Clinical/Nonclinical Writing, Labeling, Regulatory BPO and Publishing for Global BioPharma . Regulatory Affairs teams at MakroCare also supports regulatory advisory and full service dossier management for sponsors. Furthermore, the CoE team will bring pre-integrated service offerings and regulatory best practices to add value to clients’ processes for greater efficiency.
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