Confidence Beyond Compliance
Outsourcing some or all aspects has become a standard part of drug development and marketing in the pharmaceutical industry. Identifying a specific customizable model that matches the needs and strategy of the organization, is an important first step in this process. PharmaLex offers various options with flexible staffing from short-term tactical support to long-term strategic partnerships.
Place your Pharmacovigilance, Epidemiology, and Risk management activities (PER) in experienced hands. Whether you need an urgent solution for an unexpected problem or are seeking to outsource entire PER processes – our knowledgeable experts will be there for you no matter where you are.
We can provide support in;
- ICSR management, including collection, evaluation, processing, distribution and reporting
- Safety database hosting and support
- Literature monitoring
- Signal management
- Risk management
- Periodic safety reports
- Pharmacovigilance system and compliance
- EU-QPPV / local QPPV
- Quality system, audit and inspection support
- Safety data exchange agreements