Sanjeevani addresses the regulatory and strategic drug development needs of pharmaceutical companies of all sizes. Product specific regulatory/compliance and clinical advice and strategy at the early stages of product development can be critical to the ultimate approval of the product. Failure to address regulatory and compliance concerns early in the development program often results in delays in approval due to improperly designed studies, omitted studies, manufacturing oversights and other failures to meet key regulatory requirements.
Sanjeevani has a team of experienced professionals, driven by a hands-on work ethic and unencumbered by the administrative processes of a larger company, who can deliver a high quality product in a timely manner at a reasonable cost. Our team provides Regulatory Services, Quality Control, Quality Assurance, Report Writing and Training Services for the Pharmaceutical Industry.
Sanjeevani provides regulatory services to facilitate all stages (Phases I-IV) of drug development. We accomplish this by providing interdisciplinary strategy planning to obtain the most effective and efficient regulatory pathway towards regulatory authorizations. Utilizing extensive experience and applying learning across projects, the team is able to effectively handle a wide variety of regulatory challenges and helps our sponsors meet exigent timelines. Our ability to assist sponsors obtain regulatory approvals is supported by a deep understanding of, and experience in dealing with the Indian drug control regulations. We have the ability to provide services as a complete study management and/or as customized services.