Post Marketing Surveillance
Post Marketing Surveillance
Veeda offers broad spectrum of high quality, flexible, cost effective and scalable safety monitoring services that can fit seamlessly into your process, meeting all regulatory compliance requirements. We provide a global strategy for a cooperative partnership with our clients in drug safety management for US, EU, India and ROW countries. The team is powered by highly specialized pharmacy and medical professionals. We endeavour to constantly build on optimal processes complimenting client’s needs.
- Drug safety database support (VINCURA)
- Individual Case Safety Report (ICSR) management: Processing, Quality review, Medical review and Global reporting
- Literature screening
- Risk Management Plan (RMP) writing
- Aggregate report writing - PSUR, PBRER, PADER and ACOs
- Medical information management including call centre support
- Preparation of Pharmacovigilance System Master File (PSMF/PvMF)
- Qualified Person Responsible for Pharmac/ovigilance (QPPV), Pharmacovigilance Officer in Charge (PvOI) and Local Responsible Person for Pharmacovigilance (LRPV)
- Extended Eudra, Vigilance Medicinal Product Dictionary (XEVMPD)/Identification of Medicinal Products (IDMP) entries and maintenance
- Signal Detection and Evaluation
- Pharmacovigilance Training and Consultancy
- Recommendations for Pharmacovigilance department designing, development and improvement.
- Pharmacovigilance Quality Assurance including SOP development
- Audits and support for Inspections
Safety Database -VINCURA
To help our client meet ever increasing regulatory Pharmacovigilance obligation, Veeda has created Proprietary comprehensive offering of high quality, regulatory compliant services and database, perform by highly trained professionals in cost effective manner. Our one stop Pharmacovigilance solutions can fit seamlessly into your process, meeting all regulatory compliance requirements along with the very best of Pharmacovigilance training & consultancy.
Vincura is an advanced proprietary software solution that fulfils all Pharmacovigilance and risk management requirements while ensuring global regulatory compliance with below specification:
- Compliant with ICH and 21 CFR Part 11 guidelines
- Integrates E2B (R3) requirement
- Easy Data Migration - XML file import and export
- GAMP 5 Validation
Key Features of
- Inbuilt global scientific literature management module, interface with any literature database
- Auto-narrative function limiting manual efforts
- Auto-Scheduling of Aggregate reports
- Global dictionary support (MedDRA, WHODD, etc)
- User productivity report
- Simple user friendly and cost effective
Value proposition of Veeda’s Pharmacovigilance Services
- A flexible range of safety monitoring services to precisely compliment client’s needs.
- High-quality Pharmacovigilance services compliant with regulatory requirements.
- A scalable operations achieving quality and efficiency objectives
- A very cost effective pricing model
- Veeda is an Independent Indian CRO with 16 years of experience.
- Veeda has conducted over 3400+ studies & has worked with over 200 (Bio) pharmaceutical companies around the world.
- Veeda has an exemplary regulatory record of successfully completingaudits of USFDA, AGES, MHRA, ANVISA, WHO, NPA, ANSM, MCC, DCGI & NPRA
- Due to stringent quality norms and transparency at all stages, Veeda is considered to be a preferred partner for many (Bio) Pharmaceutical companies
- Veeda’s has a vast experience in scientific and regulatory compliant protocol designing that enables the drug development process of Early to Late phase clinical trials
- Veeda has over 600+ analytical methods & 60+ NCE molecules developed and validated so far
- Veeda ensures study specific clinical safety measures for all subjects through risk mitigation strategies
- Veeda has Quality Management System in place to capture any non-compliance or deviation identified during the study with an effective mechanism of corrective and preventive actions implemented