GB Pharma Group
GB Pharma Group is not only a CRO (Clinical Research Organisation) but also a CSO (Contract Safety Organisation) and Regulatory Affairs Services Company.
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| GB Pharma Services & Consulting srl - CRO | |
|---|---|
| Type | Private |
| Industry | Pharmaceuticals |
| Founded | 2001 |
| Slogan | Your Best Partner |
| Headquarters | Pavia, PV,Italy |
| Number of employees | 11-50 |
History
GB Pharma Services & Consulting srl was founded in 2001. Its founder has gained a significant professional experience in pharmaceutical companies and CRO. The management and the team of experts with the most important and crucial roles have a pharmaceutical and biomedical training with previous work experience in multinational and national companies. The company is supported by a Scientific Board for managing all kinds of medical and strategic decisions. The Board is made up of experienced doctors in different therapeutic areas. All services are made on the basis of quality system certificates.
Services
- Clinical & Observational Research
- Pharmacovigilance
- Regulatory Affairs
- Quality Assurance
- International Activities
Pharmacovigilance Post-Marketing services
- QPPV acting on “sponsor Behalf” and “owner” of Pharmacovigilance System Master File ( PSMF) and whole management of role in strict collaboration with MAH
- Local representative for AIFA on behalf of the client and acting as QPPV or/and “QPPV Deputy“ with Back-up services 24 hours / 7 days
- Use of GB Pharma Standard Operating Procedures (SOPs) and preparation/implementation the Regulatories ones for the client
- Managing Spontaneous ADR (Local, from Library Search, Extra EU)
- Literature screening (local/worldwide)
- Renting of Validated Safety Database (in compliance with E2B R3 Ich HL7 standard)
- Eudravigilance’s management on behalf of the client
- Pharmacovigilance Audit
- Database management of SAE / AE
- Case entry into Eudravigilance – EMA Database via EV-Web and into Safety DB
- Download of case from the RFN (Rete di Farmacovigilanza Nazionale – NPN (National Pharmacovigilance Network) on behalf of the customer
- Training of company personnel on Pharmacovigilance
- PSUR’s (Periodic Safety Update Report) preparation
- CCSI’s (Company Core Safety Information) preparation
- Risk Management Plan preparation
- ICSR’s medical evaluation
- Signal detection on routinely basis
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