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Pharmacovigilance
Services
National/International Literature Search
Use of PharmaSoft Database (PharmaBase)
Pharmacovigilance System Setup
Quality of a Pharmacovigilance System
Writing of In-House Pharmacovigilance Procedures (SOPs)
Preparing Pharmacovigilance System Master File (PSMF)
Preparing Risk Management Plan (RMP)
Preparing Periodic Benefit/Risk Evaluation Reports (PBRERs)
In-house Pharmacovigilance Trainings
Pre-audit consultancy/Mock audit
Preparing/ Closing Corrective and Preventive Action Plan
Adverse Reaction Management
Follow-up Safety Warnings
Preparing Dear Healthcare Professional Letters - Dear Doctor Letters
Cosmetic Adverse Event Reporting
Preparing Medical Device Vigilance Reports
Crisis Management
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Regulatory Affairs
Preparation of Type IA, Type IB, Tip II variation dossiers
Preparation of renewal registration dossiers
Preparation of license transfer dossiers
Preparation of Traditional Herbal Medicinal Products registration dossiers
Preparation of Veterinary Medicinal Products registration dossiers
Module 2.4 non-clinical summary and Module 2.5 clinical summary preparation
Last check of registration dossiers before submission
Translation of registration dossiers
SmPC-PIL preparation/ update/translation
Follow up of national/international regulatory affairs legislations and guidelines
Compliance with regulations and guidelines change
PIL (Personnal Information Leaflet) Readability Test
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Pharmacovigilance
Software Solutions
Pharmacovigilance database
Data Warehouse & Business intelligence
Data validation
Mobile device management
IT outsourcing services
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