SciencePharma offer service "PHARMACOVIGILANCE"
Basic Information
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3.8(47)
Category
Subcategory & Sub-subcategory
Trade Type
Offer Service
Service Name
PHARMACOVIGILANCE
Details
Specifications
- Service Category: Full or partial pharmacovigilance system service built on Good Pharmacovigilance Practices (GVP), covering ICSR management, signal detection, and PSUR generation.
- Regulatory Certification: Handles MAH registration and responsible-person duties for EudraVigilance, with electronic reporting to EMA and competent authorities via EVWEB or company gateway; beyond this, specific certifying bodies are not detailed in the listing.
- Capacity Scale: Batch/capacity scale is not disclosed in the listing; production is positioned for commercial contract-service volumes.
- Geographic Coverage: Manufactured/supplied from Poland, with export availability to international pharmaceutical customers.
- Lead Time: Lead time is not specified in the listing; it is confirmed directly with the supplier at the time of order.
Other Information
Additional Description:
SciencePharma has built a complete pharmacovigilance system aligned with Good Pharmacovigilance Practices (GVP), covering all quality dimensions, and makes it available to clients as full or partial services. The experienced team delivers comprehensive individual case safety report management (intake, tracking, processing, MedDRA coding, medical review, follow-up, reporting), signal detection, PSUR preparation and timely submission to authorities, addenda to the clinical overview, weekly literature searches, MAH registration with EudraVigilance, a responsible person for EudraVigilance activities, electronic reporting to EMA and national authorities (via EVWEB or company gateway), and product information maintenance.
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