We give the following services with my partners and team mates
- Giving support and guidance on preparation of the dossiers for new application according to the regulation in the region
- Giving support on the preparation of Type Variation dossiers, Marketing Authorization Transfer dossiers according to the regulation
- Giving support and consultancy on the regulatory affairs project management and regulatory strategy
- Video and audio meetings in order to troubleshoot the issues and planning of the projects in different regions
- Following up regulatory procedure of the project with local contacts and giving reports to the team providing a good and strong communication
- Having meetings with MoH in different regions through local contacts
- Finding solutions for the deficiencies and questions asked by the health authorities during the procedure and preparing the response reports for the health authorities
- Doing the research and GAP analysis about the market and guiding on regulatory compliance of the product according to the regulation in the region
- Supporting with the contacts and network in regulatory, PV and marketing activities.
- Finding niche products for companies, giving the GAP analysis and P&L analysis, informing about the tendency, supporting with contacts.