Unsere Leistungen

Drug Approval

We provide all you need for a drug approval:

• Development of approval strategies for national or European regulatory procedures, including the preparation of relevant documents: Decentralised Procedure [DCP] and Mutual Recognition Procedure [MRP]

  
  

• Planning, implementation and coordination of all activities related to national and international drug approval applications from the phase of planning to approval

  
  

• Consultation on the development of generic drugs and support for in-licensing of products, such as the search for suitable licensees and evaluation of the documentation

  
  

• The Assessment of the dossier before submission to the responsible authorities (Due Diligence Activities). Preparation of briefing documents for the communication with regulatory authorities

  
  

• Compiling the medicinal dossier into the electronic Common Technical Document [eCTD] format for electronic submission

  
  

• Authoring of nitrosamine risk analysis

  
  

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Product Maintenance & Quality Control

Our range of services covers the following aspects of product maintenance:

• Renewals as well as updating of quality documents, expert or usage information

  
  

• Formatting of CMC documentations in the current Notice to Applicants [NtA] format and creation of the documentation for the electronic submission

  
  

• Creation of change notifications according to national requirements and directives of the european Variation Guideline

  
  

• Implementation of type IA, type IB and type II changes including worksharing procedures for all aspects of the variation guideline as well as electronic submission of all necessary documents in consideration of national requirements and deadlines>

  
  

• Compiling the documents for the change view into the electronic Common Technical Document [eCTD] format for the electronic submission

  
  

Quality control covers a large area of our project management. Regardless of that, we provide the following services:

• Creation and customization of internal SOPs as well as Regulatory Compliance Files (RCF)

  
  

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Scientific Activities

We also offer comprehensive support in the area of scientific activities:

• Preparation and update of SmPC, Package Leaflet and Label information within the scope of national and European approval procedures.

  
  

• Response to medical questions with support of specialised literature, using database and internet research

  
  

• Commission of "user tests" and bridging reports

  
  

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