REMEDIA Regulatory Affairs Team, with a history of over 30 years of expertise and experience in the field, provides support for the following activities:
- authorisation, re-authorisation and post-authorisation; (maintenance through variations, updates of authorization files, etc.), for medicinal products for human use;
- notification/registration of food supplements, medical devices and cosmetic products;
- authorizations through national, decentralized (DCP) and mutual recognition (MRP) procedures;
- intermediation of readability tests for newly registered medicines;
- submission of documentation to NAMMDR in order to obtain the advertising authorization;
- claw back and volume cost services;
- adverse reactions monitoring services in specialized magazines for informing partners;
- obtaining import authorizations for psychotropic and narcotic drugs;
- obtaining authorizations for special needs;
- pharmacovigilance services;
notification of external partners regarding legislative changes regarding product registration in Romania.