Regulatory Services

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Our consultancy department Interdos Pharma, the Basic Pharma pharmaceutical service provider, can assist you in your regulatory approval procedures, both nationally and by Mutual Recognition Procedure (MRP) or DeCentralised Procedure (DCP).

Our Regulatory services include:

  • Development of EU-CTD registration dossiers (also for parallel-imported products)
  • Regulatory support for Marketing Authorisation Applications and Life cycle management for national, MRP and DCP procedures
  • Development and update of Investigational Medicinal Product Dossiers (IMPDs)
  • Writing or translation of Summaries of Product Characteristics (SmPCs),
    patient information leaflets (PIL) and labeling
  • Performance of readability-studies for PIL
  • Preparation of quality overall summaries, clinical and pre-clinical overviews
  • In-licensing and out-licensing of registration dossiers and Marketing Authorisations
  • Assistance in Technical file maintenance for medical devices (ISO 13485, ISO 14971)