Confidence Beyond Compliance
The marketing authorization applicant/ holder shall have the necessary means to fulfil the tasks and responsibilities listed in EU Directive 2001/83/EC as amended by EU Directive 2010/84/EU.
If required, PharmaLex can take on the tasks and responsibilities of the EU Qualified Person Responsible for Pharmacovigilance, or provide a deputy in times of absence or illness. Key tasks of the EU-QPPV comprises:
- Ongoing monitoring of the benefit and risks of medicinal products.
- Maintenance of the Pharmacovigilance System Master File.
- Serving as point of contact to Regulatory Authorities with 24 hours availability.
PharmaLex can also support clients with the nomination of Pharmacovigilance contact person at national level, responsible for the maintenance of the local Pharmacovigilance System, and based on the EU Member States requirements
- Clinical Trial Applications
- Clinical Trial Safety Support
- Commercialization Readiness
- Global Procedure Management
- ICSR (Individual Safety Case Report) Management
- Interim / Contract QA
- Literature Monitoring & Screening
- MAA / NDA Submissions
- Market Access
- Marketing and Labeling Activities
- MedTech Services
- Pharmacovigilance Consulting
- Pharmacovigilance Systems
What our clients say
I have found the quality of both work and personnel to be unparalleled. Rina and the team have taken much time and care to understand our business and brand objectives. They have worked tirelessly to assist with a solutions-based focus and have maintained extremely high standards to support us. I cannot imagine another supplier providing this level of service.
National Professional Relations Manager, AstraZeneca
I just wanted to relay our sincere thanks to you and the team for two really excellent days training. It was well organized and structured to cover regulatory expectations, GMP principle and routine work challenges of industry. The presenters and moderator were highly skilled in this area to accommodate any queries raised during the training session and were well able to keep the team engaged even in remote/virtual training session. The design of training slides was impressive and the use of technology to make virtual training was remarkable.
Compliance Lead, Qualified Person, Amneal Ireland Limited