GAP Assessment on Client’s Nitrosamine Risk Assessment (Step 1)
Review of your internal risk assessment (on one drug product, no limits on markets or number of APIs; the service can also be booked for the same activity on a detailed drug substance report; however, maximum of 100 pages will be reviewed.)
Commentary on potential gaps and potential recommendations for improvement.
Suggestions for improvement or potential vulnerabilities.
The package review covers technical accuracy, regulatory alignment, data gaps and logical flow.
No full rewriting of risk assessment
Structured summary assessment report format will be provided to the Client
Completion within 14 days of delivery of Client’s materials (shorter turnaround can be requested in the order form).
Logistics & Options
Lead time: 14 days (following receipt of all Client inputs).
Urgency option: Fast-Track option of 3 days (following receipt of all Client inputs) for an additional fee of € 1,250.00, subject to confirmation of consultant availability.
Booking & Payment Terms
1-year validity: The Client must enable the execution of the service within one year of the date of purchase. After the 1-year validity, an extension might be applied for up to 2 additional years, provided that a price indexation adjustment is mutually agreed upon by both parties.
The pricing is based on immediate checkout via the website (full or partial prepayment). Alternatively, corporate orders can be placed via email by submitting an official Purchase Order (PO) to hello@clarbonyx.com.
Our standard Terms apply to all orders unless an alternative agreement is explicitly in place. To establish a specific framework agreement with Clarbonyx, we recommend completing our "Become a Client" form.
GAP Assessment on Client’s Nitrosamine Risk Assessment (Step 1)
Review of your internal risk assessment (on one drug product, no limits on markets or number of APIs; the service can also be booked for the same activity on a detailed drug substance report; however, maximum of 100 pages will be reviewed.)
Commentary on potential gaps and potential recommendations for improvement.
Suggestions for improvement or potential vulnerabilities.
The package review covers technical accuracy, regulatory alignment, data gaps and logical flow.
No full rewriting of risk assessment
Structured summary assessment report format will be provided to the Client
Completion within 14 days of delivery of Client’s materials (shorter turnaround can be requested in the order form).
Logistics & Options
Lead time: 14 days (following receipt of all Client inputs).
Urgency option: Fast-Track option of 3 days (following receipt of all Client inputs) for an additional fee of € 1,250.00, subject to confirmation of consultant availability.
Booking & Payment Terms
1-year validity: The Client must enable the execution of the service within one year of the date of purchase. After the 1-year validity, an extension might be applied for up to 2 additional years, provided that a price indexation adjustment is mutually agreed upon by both parties.
The pricing is based on immediate checkout via the website (full or partial prepayment). Alternatively, corporate orders can be placed via email by submitting an official Purchase Order (PO) to hello@clarbonyx.com.
Our standard Terms apply to all orders unless an alternative agreement is explicitly in place. To establish a specific framework agreement with Clarbonyx, we recommend completing our "Become a Client" form.