Service Category: Pharmacovigilance services covering EU/local QPPV representation, PV system setup and review, ICSR management, ongoing signal monitoring, and PSUR/PBRER/DSUR/PADER/RMP reporting.
Regulatory Certification: Maintains a full PV quality system including PSMF, SOPs, internal/third-party audits, mock inspections, and CAPA writing; 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 France, 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:

Offers EU and local QPPV services; pharmacovigilance system setup and review; ICSR management; ongoing monitoring and signal management; literature surveillance; risk management; reporting (PSURs, PBRERs, DSURs, PADERs, RMPs); safety data exchange agreements; PV quality system support including the PSMF, SOPs, internal and third-party audits, mock inspections, and CAPA writing; and training.

Ratings

(0)

Leave your rating & comment

Comments

Filters:

Sort by:

No comments available.

Matched Products & Services

B2B matches based on trade type, category, specifications & price range

Explore More

Similar Products & Services

Products & Services related to what you're viewing