Regulatory Affairs
Valentis works closely with its partners to develop a comprehensive strategy for registering each product. We realize that time-to-market is one of the critical components of being successful, which is why we have invested a considerable amount of our resources in establishing a talented team of professionals to manage product registration.
Our regulatory affairs department has a commitment to:
- Providing comprehensive management of the regulatory process.
- Managing document control and procedures.
- Supervision of coordination of Regulatory Advisors at the local level.
- Closely managing the relationships between Regulatory Authorities and our Vendors.
- Preparation of the high-level translation of Product Information and Labeling in compliance with local requirements.
- Maintaining up-to-date information of EMEA, local standards, and the procedures for regulatory submissions.
- Maintenance of the Pharmacovigilance System.
- Pharmacovigilance/Medical Education.