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Strategic Regulatory Partner for Success in Venezuela
Greetings from
Pharma Wizard Venezuela
With a growing demand for imported medicines reflecting the governmentās efforts to regulate the pharma sector, Venezuela offers a great deal of opportunities for foreign medicine or medical device manufacturers. However, to get Venezuelan market access, pharmaceutical companies must obtain market authorizations from MPPS (Ministry of Health) ā El Ministerio del Poder Popular para la Salud (for medical devices: Servicio Autónomo de ContralorĆa Sanitaria [SACS] and Instituto Nacional de Higiene Rafael Rangel [INHRR]). En route, right from requiring an authorized representative, organizations might have to undergo complex regulatory procedures for successful registrations and authorizations.
Pharma Wizard, as an exclusive global Regulatory partner, assists organizations to keep abreast with the Venezuelan regulatory market changes and supports the preparation of local dossier documentation for submissions and approvals of new registrations and authorizations. Pharma Wizardās exclusive Regulatory services in Venezuela span across:
Pharma Wizard, as an exclusive global Regulatory partner, assists organizations to keep abreast with the Venezuelan regulatory market changes and supports the preparation of local dossier documentation for submissions and approvals of new registrations and authorizations. Pharma Wizardās exclusive Regulatory services in Venezuela span across:
- Medical Device
- Pharmaceuticals
- OTC
- Natural Products
Pharma Wizard Offerings
- Strategic Regulatory Consulting
- Regulatory Affairs & Regulatory Intelligence
- Registration Pathways and License Management Services
- Product Registrations and CMC Changes
- Maintenance and Product Renewals
- Regulatory Submissions and Publishing
- Common Technical Documents (CTDs)
- Periodic Safety Update Reports (PSURs)
- SmPC, Patient Leaflet, Labeling
- CMC Change Control
Pharma Wizard Advantages
- Strategic Local Health Authority Contacts ā with MOH, INHRR
- Expert Regulatory Team with Proven Global RA Expertise
- Proactive and Collaborative Approach
- Quick Turnarounds and Faster Time-to-Market
- Keeping Abreast with Region-Specific Legislation and Regulatory Guidelines