Clinical Trials Day

REGULATORY

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.

Clinical study protocols and amendments
Investigator Brochures
Clinical study reports: Phase I, Phases II-IV
CTD: Summary of Clinical Safety; Summary of Clinical Efficacy; Clinical Overview
Periodic Safety Update Reports
Annual Safety Reports
Risk Management Plans
Patient Safety Narratives
Standard Operating Procedures (SOP’s)
Informed Consents

SCIENTIFIC WRITING

Abstracts
Manuscripts
Journal Submissions
Conference Materials
Literature Search & Review

EXPERTISE

New chemical entities
New biological entities
Generics / Biosimilars (rDNA products)
Monoclonal antibodies
Medical devices
Neutraceuticals

SERVICES

Regulatory dossier compilation, including CTD and eCTD format
Regulatory approvals for Phases I-IV clinical trials including new indications and special population studies Conducting
BA/BE studies
Export NOC for biological samples for testing
Approval of Import license of drugs
Safety reporting
Product registration for marketing approval
Strategies on global CTD and eCTD regulatory submissions that conform to US FDA and ICH guidelines