- Communication with interested parties
- Management of Joint Submission/Data Sharing agreements
- Calculation of Letter of Access (LoA) or License to Use (LtU) fees
- Issuing invoices and monitoring incoming payments
- Provision of tokens, LoA documents and other files (e.g. IUCLID, CSR, RSS) required for registration
Our comprehensive LoA and data sharing management includes the following services:
LoA sale process
Recalculation and reimbursement of beneficiaries (e.g. data holders)
- Recalculation of LoA fees and calculation of the amount to be reimbursed per beneficiary
- Obtaining bank details
- Issuing a credit note to the beneficiary
Trustee account management
- Set-up and management of trustee accounts by our financial experts and tax advisors
- Administration of LoA and LtU fees on the individual trustee accounts for our customers
Joint Submission Communication
- Representation of the lead registrant in the Joint Submission
- Communication with the Joint Submission members on behalf of the lead registrant (e.g. inform
about agency decisions, new testing, dossier updates)
Data Archiving
- Documentation and required data updates
- Data archiving/storage for 10 years