Pharmacovigilance is the scientific discipline that deals with the detection, assessment, understanding and prevention of adverse effects or any other drug related problems. It involves monitoring the safety of drugs and medical devices after they have been approved for use in the market. It helps in identifying previously unknown side effects or adverse reactions that may occur when a drug is used in the general population. It is an essential part of drug development, regulatory approval, and post marketing surveillance. It helps to ensure the continuous improvement of drug safety and contributes to the protection of public health.
Bioagile Therapeutics Pvt.Ltd, headquartered in Bangalore, India, is specialized in offering holistic knowledge-based end -to-end pharmacovigilance services to pharmaceutical companies around the globe. Our leadership team is composed of qualified physician scientists with a rational blend of intelligence, experience and reputation.
Pharmacovigilance Services includes:
Expertise in processing ICSRs from all sources which includes spontaneous reports from health care professionals, consumers, health authorities, Eudra Vigilance, literature, LP, clinical trial reports, MAP cases, SUSAR etc. We process both serious and non-serious cases. Specialised tracking tools for work management, well designed workflow, trained managers for quality and timely submissions. Dynamic team with experienced physicians and associates capable of handling reports. Trained physicians for MedDRA coding and labelling.
- Reports from all sources
- Post Marketing Surveillance/Clinical Trial
- Book-in/Triage/24/7 case management
- FDE into Argus
- MedDRA coding
- Medical Review
- Narrative Assessment
- Product Quality Complaint Management
- E2B submissions to all regulatory authorities
Our AR team consists of physicians who have a combined experience of authoring about 1000 reports over the past 5 years, including various types listed here, over multiple therapeutic areas and across both generic, innovator molecules and vaccines. The team works in close conjunction with the RMP physicians so that the content of these reports is synchronized, and therefore is an ideal solution for clients who are ready to outsource the entire range of PV services.
- Line Listing generation for Products
- Aggregate Data Analysis
- ICH E2C, GVP, USFDA, CFR 314-80, EVMDR, MedDEV 27.1 Rev4
- All types of reports PSUR, PADER, PBRER, DSUR, AdCO, SSUR
End to end expertise in signal management with an experienced team capable of doing signal detection, validation, confirmation, prioritization, assessment and in drafting the signal assessment report. We also have experience in performing review of additional data on the signal in the following PSUR or submit an ad-hoc PSUR, updating the product information, providing content for use in RMP submission. We are experienced in providing signal management activity for both generic and innovator molecules, vaccines and biologics.
- Signal Detection/Validation/Confirmation
- Signal Analysis and prioritization
- Signal Assessment
- Recommendation action
- Regulatory Submission
Risk Management Plan
Our expert team has the prerequisites to support RMP submissions to regulatory authorities worldwide. Our experience authorities worldwide. Our experience includes all therapeutic areas with both the legacy (1.0) and the current (2.0) version RMP templates with implementation of HaRP (Harmonization of RMP Project) regulations for all types of RMPs of varying complexities including developmental and emergency/compassionate use. We cover end to end activities involved in the drafting of RMPs including preparation of list of safety concerns as well as PI/SmPC updates based on recommendations from PRAC, CHMP, and regulatory authorities.
- EU RMPs, REMs
- Medical Guidelines/EM
- Submission to all RA
- Evaluation of Effectiveness
- HaRP Regulation Compliance
- Risk Analysis and Evaluation
- Risk Control
- Post Marketing Surveillance
Medical Information System
In the dynamic field of pharmacovigilance, where ensuring the safety and efficacy of pharmaceutical products is paramount, Bioagile stands out as a leading provider of Medical Information Services to pharmaceutical companies. These services are designed to address the critical need for prompt and accurate dissemination of medical and safety information, encompassing essential elements such as adverse event management and regulatory compliance.
- 24 x 7 Global Contact support centre.
- Literature Monitoring
- Adverse Event Monitoring and Continuity
- Receiving and Addressing Product Complaints