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Pharmacovigilance
Our Pharmacovigilance consulting services are spread across the entire product life cycle of Starting from product development program, clinical development, Marketing authorization and post marketing reporting to regulatory bodies periodically
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Clinical Trials Safety Support
Clinical trials are very important in product development to ensure the safety and efficacy. The safety data generated during clinical trials of new drug developments or bioequivalence generic drug development must be reported the concerned regulatory authorities as per the guidance.
We work with various stakeholders, Sponsors CROs, multiple sites and investigators and with data safety monitoring board committees. With an exceptional clinical experience we can offer
Developing robust clinical study safety reports, design and implement safety procedures Management of Serious Adverse Event (SAE) including narrative writing, codifying event terms according to MedDRA, concomitant medication using drug dictionary
Prepare and send of follow-up requests, expectedness assessment of Serious Adverse Reactions (SARs)
Report of unblinding, report Suspected Unexpected Serious Adverse Reactions (SUSARs) to the National Competent Authorities, Ethics Committees (ECs), Institutional Review Boards (IRBs), and investigators
Prepare and submit Development Safety Update Reports (DSURs), the safety sections for Investigator Brochures (IBs) updates and Investigational Medicinal Product Dossiers (IMPDs) or create bespoke safety reviews in response to regulatory authority requests
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Pharmacovigilance Support
Safety reporting in Market authorization and post marketing surveillance is crucial in product life cycle and it require experienced staff, we have consultants those have exemplary skills in handling Pharmacovigilance activities.
Pharmacovigilance System Master File (PSMF) containing all the details of the product and for each application we prepare and maintain Pharmacovigilance System Master File including the qualified person for pharmacovigilance management
Processed based Audits will be conducted at on site, to focus how team members are prepare, produce, document, package, distribute those products gives us thorough understanding of the steps to streamline the effective processing
We provide flexible solutions Expedited Reporting, Risk Management Plan (RMP), Risk-Benefit Assessment, designing, implementation of risk minimization strategy and its management
We provide very important Periodic Safety Update Reports (PSUR) and Safety Exchange Agreements (SEA) over a defined interval based on standard regulatory format and these documents are essential during regulatory inspections