Having a regulatory affairs and pharmacovigilance strategy that is appropriate to your product, while also taking into account the various requirements from different functions within your organization is critical to success and ensuring that you have the right path forward for your product to reach patients.
Regulatory Affairs & Pharmacovigilance
Experts in regulatory and pharmacovigilance strategy design and implementation, ensuring safe and compliant product supply.
Interacting with regulatory agencies and ensuring compliance with marketing authorization/application obligations takes a cross-functional approach to ensure companies are operating in a legal and regulatory compliant fashion. Orphan Drug Consulting’s experienced team can advise and guide companies along this process in both existing and future countries/markets, taking the country-specific nuances and intricacies of the region and creating a roadmap for success.
Key Strategy Impacts
- Regulatory and Pharmacovigilance Strategy Design and Implementation
- Input into Product License Submissions and Approvals
- Named Contact on Regulatory Licenses
- Support Selection of QPPV Service Providers to Comply with EU Marketing Authorization Requirements
- PSMF Creation Input
- Vendor Selection Services to Manage Global Safety and Adverse Event Reporting
- Marketing Authorization Obligations Compliance
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