Introduction
Our mission is to help pharmaceutical companies and regulatory agencies manage their processes and electronic submissions more efficiently and transparently.
Our main focus is providing services and solutions related to the requirements defined in Article 57 of the new Pharmacovigilance legislation.
We are one of the first vendors to provide a comprehensive solution around Article 57.
We are can also provide skills and services that cannot be easily found in Europe:
- Deep understanding of the EU regulatory landscape and its complex environment
- Extensive technical understanding of the Article 57 requirements
- Practical knowledge of registering medicinal products
- Deep understanding of the dramatic consequences that Article 57 and the new Pharmacovigilance legislation will bring to the large and medium sized companies
- Practical experiences with development and implementing IT systems in pharmaceutical industry with the focus in Regulatory Affairs
- Validation of IT systems
- Clear Vision and understanding of the needs for large and medium sized pharmaceutical companies
We engaged in the development of the current eCTD guidelines and the Next Major Version of eCTD 4.0 - the RPS (Regulated Product Submissions), the Common European Submissions Portal (CEPS) and the new Pharmacovigilance requirements - Article 57 on the EU level through our work at EGA (European Generic Medicines Association).
As companies are struggling to meet the demands of Article 57, there will be a rush for any available resources. We can immediately assemble perhaps the largest group of experienced regulatory and IT professionals in Europe with aforementioned skills to be part of your project.