Consultancy
With regards to the regulatory
affairs service, we provide support
to our Clients in registration
process of pharmaceuticals, OTCs,
medical devices, cosmetics and food
supplements. For this service, we
work with the competent and skilled
experts who have considerable
regulatory experience.
The list of services we provide within this scope;
● Pre-submission assessments
● Preparation of the local documentation for
the national registrations
● Translation of the technical documentation
● Post-licensing advice; variation and
renewal applications
● Monitoring
● Reporting
● Providing update legislative information
● Advice on reimbursement policy
● Organization of meetings with the Client
and the Competent Authority, assist the Client during the meeting
● Advice on the requirements of labeling
based on the national legislative
With regards to the European Union, working together with our business partners abroad and being in close contact with the European Commission, we are providing consultancy in
The assessment of company R&D activities and the new ideas that they want to apply
The search for the best partners according to their experience and fields of activity
Dealing with the regulatory requirements and ensuring proper communication
Finding convenient financial support schemes from EU funds
The coordination and conclusion of projects
With regards to registration services, we are conducting procedures with the Turkish Patent Institute (TPE), the European Patent Office (EPO), the Office for Harmonization in the Internal Market (OHIM) and the World Intellectual Property Organisation (WIPO). We are able to benefit from our wide network of contacts, amongst well-known patent and trademark attorneys and experts in these subjects. In this area, we are providing consultancy services in,
Conducting searches in Turkey as well as abroad before making an application
Preparing application files
Following registration procedures
Following files after registration, following the relevant bulletins and
Informing clients of new developments
Exploitation of legal rights and procedures and criminal sanctions where necessary
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