In/Out-licensing due diligence
OCS supports companies with
- Pre-IND/IND interface
- Assessment of completeness of the pre-IND package and IND to ascertain
- Likely outcomes with the FDA
- If the IND package and associated FIH protocols contain sufficient to ensure patient safety, to allow a decision to made on go or no-go into mid-stage clinical development
- Early-stage clinical development
- Assessment of protocols and execution to allow a decision on dose, likely safety profile and potential clinical benefit in indications that would support a lean registration study package.
- Pre NDA submission
- Assessment of the quality and completeness of the data package to be submitted to regulatory authorities, including identification of potential weak points and planning on mitigation strategies.