We give the following services with my partners and team mates
- Determination of missing/incomplete documents of Marketing Authorization Submission Dossiers
- Preparation of submission dossiers according to TMMDA requirements.
- Providing technical and logistic support to MA Holders in the supply of missing information and documents
- Submission of the dossier in eCTD format in accordance with TMMDA requirements
- Follow up of the submitted dossier until approval of the preliminary investigation commission
- Providing technical support to the regulatory affairs department of the companies in the supplying of information and documents requested by TMMDA Regulatory Affairs Commissions
- Preparation of variation dossiers
- Preparation of Renewal of Licence dossiers
- Conducting correspondence with the Ministry Communication with foreign licensers
- Pursuance of the proceedings in Ankara
- Performing a follow-up service during the entire regulatory process on demand (replying the commission inquiries )
- Preparation of Dossiers for Pricing, Reimbursement Requirements
- Preparation of GMP Audit Dossiers
- Support for PV Activities
- Following up the projects on Business Development and giving reports on them
- Finding niche products for companies, giving the GAP analysis and P&L analysis, informing about the tendency, supporting with contacts.