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Regulatory Development

Regulatory DevelopmentKnowing where your are going will make the journey shorter and less time consuming.

The IWA Consulting Team can assist you on developing your regulatory strategies. We have significant experience in preparing for and assisting during scientific advice with international authorities.

Whether you are looking to do an Orphan Drug Application in the EU or US or considering to apply for fast track – we have the experience and expertise to see your project through to success.

Furthermore we can assist you on electronic clinical trial applications in Europe (CTAs/eCTAs) and in the US (INDs/eINDs), assisting in preparation of Investigator´s Brochures.
SME
Did you know that the EMA (European Medicines Agency) offers small and medium enterprises the possibility of obtaining SME status?

SME status is associated with financial incentives and procedural assistance. The IWA Consulting Team offers assistance for application of  SME status, and for companies located outside the EEA, SME status can be obtained through the IWA Consulting SME status.

For more information about our services within regulatory development, please contact our Regulatory & Medical Development Team