Case Study
An India based manufacturer, focused on Branded Formulations, Specialty Generic Injectables, Synthetic Biology, Vaccines and Biologics
At A Glance
Challenges
- Medical Inquiries
- Product Complaints
- Adverse Drug Experience Reporting
- Other Categories
- Combination of the above calls.
Highlights
- 2600+ Aggregate reports delivered
- 2.6 Lakh+ Cases processed
- 1.1 Lakh+ MICC Calls handled
- 3700+ Signal reports delivered
- 52 Audits & Inspections conducted
- 09 Regulatory inspections at client location conducted
Objectives
An India based manufacturer committed to delivering quality and safe products to its customers. This is achieved through a well-defined quality management system. Their quality management system is mandated and supported by executive management. While it is coordinated by the quality management department, it is monitored by departmental self-audits, internal facility audits, and quality assurance compliance programs. Regulatory agency inspections also help in assessing the robustness of our quality management system.
Countries in Scope
Yemen, Iraq, India
Solutions
End-to-end Pharmacovigilance and Regulatory activities include Medical Information Call Center, Global Literature Monitoring Individual Case Safety Reporting, Periodic Adverse Drug Experience Reports, Product compliance, intelligence, and Signal Management Activities.
Benefits
Professional Team
Medicine (Medical reviewers) and Nursing professionals and Pharmacists. Our robust backup procedures and resources
MICC Handeling
Best professionals who offer the right mix of medical and scientific knowledge combined with excellent communication skills.
Medical Literature monitoring (MLM)
Search string shall be identified and approved by the client. Document all the results obtained from the weekly literature search for quality review and final medical assessment
Case Processing and Reporting
Incidents from Medical Information Call, Medical Literature Monitoring are detailed into cases for resolution & submissions.
