ceutico consulting services offer service "Pharmacovigilance"
Basic Information
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4.6(80)
Category
Subcategory & Sub-subcategory
Trade Type
Offer Service
Service Name
Pharmacovigilance
Details
Service Provider(s)
Specifications
- Service Category: Full pharmacovigilance service covering PV master file development, SOP creation, RMP and PBRER development, ICSR submission, and signal management.
- Regulatory Certification: Includes auditing services and PV inspection-readiness support, along with SDEA review and sales-team reporting training; 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: Geographic coverage is not detailed in the listing; the supplier serves regional and 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:
Provides a full suite of pharmacovigilance services, including PV master file development and maintenance, SOP development, quality management system setup, audit and inspection-readiness support, risk management plan (RMP) development, periodic benefit-risk assessment report (PBRER) preparation, literature searches, ICSR submission, signal management procedures, safety data exchange agreement (SDEA) review, sales-team reporting training, post-authorization safety study follow-up with CROs, and additional risk-minimization materials.
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