Services

Regulatory Affairs

• Submissions and registrations of pharmaceutical dossiers in European Union
  
  QPS, through our partners, are able to handle the regulatory submissions of pharmaceutical dossiers in European Union, via national procedures, MRS (Mutual Recognition Procedure) or DCP (DeCentralized Procedure), in accordance with the particular projects and goals of each customer. Responding without delay to the deficiency letters of all European authorities is one important part of this activity, along with providing to authorities all data related to the safety, efficacy and quality of the product. Planning and executing of the regulatory and marketing strategy until obtaining of the Marketing Authorization shall be the main focuses of our teams.
  
  Regulatory Affairs consulting and support
  
  The expertise and experience of QPS’ partners and the open comminication with each of our customers enables us to provide proffessional consulting to anyone requiring it. In the same way, we provide our regulatory support to our customer by preparing of the documentation for renewals, variations, or pharmaceutical product legal status switches in all European countries, as well as regulatory support to post-submission regulatory issues.
  
  Regulatory strategy planning
  
  The close colaboration with our customers in order to understand their projects and their specific goals, gives us the possibility to ellaborate a customised marketing and regulatory strategy planning for their pharmaceutical products. This way our customers are adviced which is the best registration procedure for a certain product on a certain market, in terms of time-advantage and cost-effectiveness.

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