consult2deliver know that a robust clinical and regulatory strategy delivers long-term value and confidence to your idea or concept.
We can collaborate to create
- Investigator Brochures (IB)
- Investigational Medicinal Product Dossiers (IMPD)
- Bibliographic reviews to validate idea/concept
- Clinical strategy in line with regulation
- Clinical strategy with/without scientific advice
- Formal project planning
- Analysis of data from clinical studies (I-III) to confirm alignment with clinical strategy
- Study design and protocol preparation
consult2deliver can assist with the submission of your clinical trial application and respond directly to ethics committees or regulatory authority following a ‘grounds for non acceptance’ letter (GNA).