development

The development of new drug substances and products requires competent regulatory activities from the beginning. We are up to date with respect to all regulatory requirements during non-clinical and clinical development. If the issue at hand so requires, we cooperate with established external partners.

We have experience with different models of cooperation, as required in the respective case, from consultancy alone to taking over the entire project coordination and all activities ensuing in this context, including project management.

For young biotech or start-up companies without a development department of their own we offer their integration in our networks and our support in their project work.

Meetings with Authorities / Scientific Advice

We prepare and perform meetings with authorities for you (Scientific Advice). You are welcome to call on us to prepare such meetings, compile the necessary documentations and submit the application as well as the required documentations. Moreover we accompany you to the meetings and support you during the discussions. For preparatory purposes we perform rehearsals with you.

Cooperation with Third Parties / Outsourced Services

Apart from the services we directly offer as i.DRAS, we cooperate with external partners if required – for instance in the domain of pharmaceutical development, analytical laboratory services as well as of contract manufacturing of investigational medicinal products, toxicological testing as well as required non-clinical and clinical studies. This makes sure that, if necessary, accordingly qualified experts support the i.DRAS team or that required experimental and/or technical tests can be performed and their results are available in an appropriate quality and at the right time. We also gladly take over the overall project management in more complex projects involving different partners, so that all services are provided from one source and you can completely hand over responsibility.

 
Clinical Trial Applications
Together with the CRO responsible, we support you in preparing and submitting clinical trial applications to the competent authorities.
  • Compilation of the IMPD (Investigational Medicinal Product Dossier)
  • Compilation of the IB (Investigator's Brochure)
  • Compilation of the necessary forms
  • Compilation and submission of the application to the competent authority
  • Compilation of the IND for US-FDA
 
Gap Analyses and Check for "Regulatory Compliance"
for
  • IMPD (Investigational Medicinal Product Dossier) and IB (Investigator's Brochure)
  • Non-clinical and clinical study reports
  • CMC reports (physico-chemical characterisation of the drug substance, manufacturing development, scale-up, stability, compatibility, formulation development, impurity profiling, stability of investigational medicinal products)
medicinal products
 
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