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An average drug costs over USD 1 billion to bring it to fruition from discovery through development and launch phases. These expensive "blockbusters" face even riskier futures in the event of regulatory drug withdrawal decisions/recalls that could bring companies to closure.
Historically, such recalls have been followed by punitive public payouts in billions of dollars, forcing the Pharmaceuticals industry to embrace a paradigm shift towards predictive and proactive Pharmacovigilance.
Traditionally, Pharmacovigilance has been a labor-intensive case processing-based industry. We revolutionize this through our unique Artificial Intelligence Integrated Cloud Based Pharmacovigilance Platform offering. This unique approach promises to radically alter the Pharmacovigilance landscape, leading to better identification, reporting, and resolution of adverse events leading up to lower costs for Pharma companies and healthier patients.
Our Pharmacovigilance practice’s expertise in implementation, ASM, system validation, case processing, and aggregate reporting is backed by:
- Industry accepted GAMP 5 approach or hybrid/custom approach to meet all customer requirements
- A risk-based approach embracing recent FDA guidance, including 21 CFR Part 11, 21 CFR Part 210, Part 211, and Part 11 ER/ES Ruling interpretations and electronic data applications as pertaining to Pharmaceutical industries' data acquisition, Electronic Batch Record, Audit Trail, Closed and Open Systems
- A specialized team with access to a wealth of forms and protocol templates for validating computer systems
- Expertise in full life cycle management of computerized systems validation
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