Regulatory Affairs
27
page-template,page-template-full_width,page-template-full_width-php,page,page-id-27,page-child,parent-pageid-23,bridge-core-3.1.8,cookies-not-set,qode-page-transition-enabled,ajax_fade,page_not_loaded,,qode-title-hidden,qode_grid_1300,footer_responsive_adv,qode-child-theme-ver-1.0.0,qode-theme-ver-30.5,qode-theme-bridge,wpb-js-composer js-comp-ver-7.6,vc_responsive

Regulatory Affairs

Regulatory Affairs

We provide a wide range of services related to pre- and post-submission issues in pace with product lifecycle

 

  • Regulatory strategy advice and execution
  • Regulatory submissions under DCP/MRP¹ and pure NP²
  • Post-marketing applications and MA³ maintenance support
  • Linguistic support for product information of CAPs⁴
  • Regulatory intelligence
  • Regulatory documentation assessment and upgrade
  • Compilation of quality, non-clinical and clinical overviews and summaries
  • Readability testing of package leaflets
  • Consultancy on promo and educational materials
1. Decentralized / Mutual recognition procedures (DCP/MRP); 2. National Procedure (NP); 3. Marketing Authorisation (MA); 4. Centrally Authorized Products (CAPs)

Related posts from our blog