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 CTA 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, CDRH, MHRA, HPB or EMA.  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, CTA 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.

Some of the services we offer are :

Submissions

• Product definition, development and submissions for IND and CTA.
• 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 with the agency

Inspections

• Preparation for PAI and PLI and conducting mock inspections
• Preparation for routine inspections
• Responding to inspectional observations including warning letters and other stronger actions

Reporting

• Filing Field Alerts, Biological Deviation Reports and conducting Recalls
• Drug safety programs and filings.

We look forward to discussing with you your needs and developing a program that is both cost effective and fits your timetable