PharmaLex
From Verify.Wiki
In October 2015, YES and PharmaLex, merged to form a powerful, new service provider in the fields of Development Consulting & Scientific Affairs, Regulatory Affairs and Pharmacovigilance. Through this merger, PharmaLex has increased its ability to provide existing clients a broader range of services. Additionally, the company is now positioned to competitively fulfill the needs of an extended global client base. With 650 employees dedicated to providing quality service and expertise, PharmaLex is the one to partner with in the regulatory field.
 | |
| | |
| PharmaLex | |
|---|---|
| Type | Private |
| Industry | Pharmaceuticals |
| Founded | 1998 |
| Headquarters | Frankfurt |
| Number of employees | 501-1,000 |
Contents
Services
Development Consulting & Scientific Affairs
- Development strategy and gap analysis
- Clinical trial designs
- Health authority briefing documents
- Scientific advice and health authority meetings
- Due diligences
- CTD clinical & nonclinical documents
- PIP / PIP waiver, pediatric study plans
- Environmental risk assessment
Regulatory Affairs
- Procedure management / health authority contact
- Electronic submission services in all formats
- Change control procedures / CMC writing
- CCDS development and worldwide roll-out
- Full maintenance service
- Initial marketing authorization application
- Line extensions and referrals
Pharmacovigilance
- Risk management
- Signal management
- Periodic safety reports
- Pharmacovigilance system and compliance
- EU-QPPV / local QPPV
- Quality system, audit and inspection support
- Safety data exchange agreements
- ICSR management, including collection, evaluation, processing, distribution and reporting
Top Authors
Verification history
1,702 days ago
2,706 days ago- View all verifications
