We offer you support in the regulatory management of clinical trials applications (CTAs) and Investigational New Drug (IND) applications. Our services include but are not limited to:
- Compilation of CTAs according to the newest national requirements
- eIND compilation according to eCTD specifications including management of IND serials by using eCTD life cycle (see also “emerging submission dossier”)
- Strategic regulatory input and liaison with the FDA regarding INDs (through our partnership with Grace Pharma LLC, NJ, US)
- Compilation and review of IMPDs (Investigational Product Dossiers), Investigator’s Brochures, Study Protocols
- Preparation and Review of EU CTA documents (e.g. EudraCT forms)
- Managing of EVMPD entries
- Managing of Clinical Trial Registries
The regulatory management of clinical trial applications and investigational new drug applications became more and more complex due to diverging national requirements following the implementation of the EU Clinical Trials Directive (EU Dir 2001/20/EC) and the introduction of electronic submission formats and processes (e.g. EudraCT).
Besides sparing the expensive and time-consuming paper work, the electronic filing of INDs (as recommended by the FDA) offers substantial long-term advantages such as the possibility to build up your future NDA submission by managing your IND serials electronically by using the eCTD life cycle functionality ("emerging dossier").
Building the documentation of clinical development projects in phases I-II eCTD format can offer strategic options and benefits regarding the out-licensing of products and due diligence processes:
The corresponding data for the product is assessable in an well-established format with minimized efforts and maximized transparency for both, potential investor / buyer and the inventor.