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.