You as our client benefit from the diversity of the projects we are currently working on and have processed in the past. Without violating the required confidentiality, experience grows from the varied demands, which we gladly share with you. Regulatory success is determined by many factors. The basis in this context is always formed by the detailed knowledge of the relevant laws and regulations, guidelines and other rules in a national and international environment. Consistent, conclusiveand comprehensible presentation and assessment of data in the dossier plays a central role. From our experience having your documentations and the underlying data assessed by an external third party contributes to ensuring smooth assessment by the relevant authority. This gives you a certain level of assurance that your documents are complete, meet the scientific and formal requirements and that the data are presented and assessed in a manner that is comprehensible for third parties.

According to the respective question on the quality, efficacy and safety of drug substances and products, the consultancy services are provided by the experts from the i.DRAS team or we identify a suitable expert in our networks.

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