Regulatory
Affairs
Affairs
Successful research and development can only lead to licensed products if you
have a well thought out and executed regulatory strategy. Submitting a complete
IND or IMP submission requires not only doing good science but also knowing
what the latest challenges other companies are having with the agencies,
whether they be CDER, CBER, MHRA, HPB or EMEA. Once trials have started,
building the complete dossier for eventual licensure or approval is critical.
These dossiers need to be constructed to minimise multiple review cycles.
After submission of the dossier, preparations must begin for pre-licensing and
approval inspections. Even when the approval is received, agencies inspect
periodically for cause or routinely. Field Alerts, Biological Deviation reports and
recalls are especially challenging to the company the first time and even
subsequently.
Calcott Consulting can aid you in your submissions for IND, IMP and NDA, BLA
and MAA because we have done them before. We have taken products from
development through licensure. We can also help you prepare for PAI and PLI
as well as responding to routine inspections and further regulatory actions eg.
warning letters and plant closures due to GMP violations. We have filed field
alerts, Biological deviations reports and conducted multiple recalls, all with
satisfactory results.
have a well thought out and executed regulatory strategy. Submitting a complete
IND or IMP submission requires not only doing good science but also knowing
what the latest challenges other companies are having with the agencies,
whether they be CDER, CBER, MHRA, HPB or EMEA. Once trials have started,
building the complete dossier for eventual licensure or approval is critical.
These dossiers need to be constructed to minimise multiple review cycles.
After submission of the dossier, preparations must begin for pre-licensing and
approval inspections. Even when the approval is received, agencies inspect
periodically for cause or routinely. Field Alerts, Biological Deviation reports and
recalls are especially challenging to the company the first time and even
subsequently.
Calcott Consulting can aid you in your submissions for IND, IMP and NDA, BLA
and MAA because we have done them before. We have taken products from
development through licensure. We can also help you prepare for PAI and PLI
as well as responding to routine inspections and further regulatory actions eg.
warning letters and plant closures due to GMP violations. We have filed field
alerts, Biological deviations reports and conducted multiple recalls, all with
satisfactory results.
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Some of the services we offer are :
 | Product definition, development and submissions for IND and IMP. | |
| BLA, NDA and ANDA submissions and their EU and Canadian | |
| counterparts | ||
| Face to face meetings to defend strategy for CMC and plant design and to | |
| gain consensus | ||
| Preparation for PAI and PLI and conducting mock inspections | |
| Preparation for routine inspections | |
| Responding to inspectional observations including warning letters and | |
| other stronger actions | ||
| Filing Field Alerts, Biological Deviation Reports and conducting recalls. | |
We look forward to discussing with you your needs and developing a program
that is both cost effective and fits your timetable
that is both cost effective and fits your timetable