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Services
We have the knowledge and experience to meet and exceed your expectations and we offer a variety of services customized to fit your specific needs. Learn more about the improvements we can help you achieve, and contact us today.
Regulatory Intelligence
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Regulatory and Technical Consulting (EDA) | (NFSA)
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Registration and Product Authorization
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Product Life Cycle Management
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Evaluation of the Impact of New Guidelines
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Price Adjustments and Cost Analysis
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Post Authorization Variations
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EDA/NFSA Queries Response and Interactions
Pharmacovigilance
Pharmacovigilance System Outsourcing
Pharmacovigilance Consulting
Pharmacovigilance Training
Pharmacovigilance Audit
SOPs Writing and Review
Quality Evaluation (RCA), (CAPA)
Vigipx is an advanced E2B Pharmacovigilance software for cases creation, reviewing and validation, generates XML files compatible with ICH E2B with automated literature search and extra tools to facilitate the management of pharmacovigilance activities
Pharmacoeconomics
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Cost-Utility Analysis
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Cost-Minimization Analysis
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Budget Impact Analysis (Fixed Model) | (Dynamic Model)
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Evaluation of pharmaceutical products efficacy compared to market similars
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Measure to what extent the product has better benefits over competitors
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Price analysis and Market Access studies
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Measurements of cost-benefit and cost-effectiveness
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Support decision making for optimal allocation of resources
Leaflets Translation, Scientific Files and Medical Writing
SmPC and PIL Medical Translation
Scientific Files Preparations
Educational Materials Preparation
Literature Screening
Safety Reports Writing
