RACON Regulatory Affairs Consulting GmbH

Professional Service & Consulting

proteona.png

CRO

RACON GmbH is a service provider.

Due to the diverse experience of the founder Dr Hans Rensland, different kind of pharmaceutica1 companies can be supported in the drug developmen,t the drug approval and the drug maintenance processes.

The company have experience in a broad range of pharmaceutical forms (e.g.: tablets, powders, eye drops, antibodies as weil as cell and gene therapy).

The following processes can be accompanied

- in EU: CTAs (Clinical Trial Applications), scientific advices and drug approval processes (MAAs) at the EMA (CPs) and the national authorities (MRP/DCP)

- in USA: IND (lnvestigationalNew Drug Application), scientific advices and approval processes (NDA/BLA).

Furthermore RACON support to maintain (renewals) and to change the approvals (variation).

Appropriate expertise is available for all modules (quality, non­ clinical, clinical) of the CTD (Common Technical Dossiers). The creation of the electronic CTD submission to the authorities takes place in-house with an industry-known eCTD software