Warning: call_user_func_array() expects parameter 1 to be a valid callback, class '' not found in /home2/r43058reme/public_html/wp-includes/class-wp-hook.php on line 308
Regulatory affairs – Farmaceutica Remedia Distribution & Logistics

Registration of medicines

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.