The Situation Today
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are constantly revising and extending compliancy requirements for the pharmaceutical industry in the light of global changes in this industry.
In this scenario, 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 pharmaceutical industry to embrace a paradigm shift towards predictive and proactive pharmacovigilance.
How HCL Can Help
HCL's pharmacovigilance practice has expertise in implementation, ASM, system validation, case processing and aggregate reporting services. It offers:
- 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
HCL has expertise on Oracle Argus, a safety platform specifically designed to provision proactive drug safety and risk management.
What You Can Expect
HCL offers the following pharmacovigilance solutions:
- Customization/ configuration
- Customized ADM
- Functional and Product Training
KPO and help-desk
- PV Call Center
- Case Processing Center
- Monitoring & Analysis
- Medical Writing
- Regulatory validation of OPA installation
- Functional Validation
- FDA Compliance Consultation
Maintenance and Support
- L1 Helpdesk Support
- L2/L3 Support
- Version Upgrade
- Application Maintenance
For more information, write to us at: firstname.lastname@example.org