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SERVICES > REGULATORY
Regulatory Writing & Support
At Co-Labb, we can offer writing support at any stage of the regulatory pathway. Not only can our team provide writing solutions, but we can also offer support and advice for your clinical development program.
With experience over a range of Investigational New Drug (IND) applications, we can provide concise and effective writing solutions on a client-specific basis.
Pre-IND Case Study
Blue Horizon International (BHI) is a leading stem cell therapy provider with clinics globally.
BHI had an abundance of patient data they had collected from their international clinical sites and now wish to pursue regulatory approval in the U.S. The Investigational New Drug (IND) application is a lengthy and challenging process that involves massive volumes of writing, alongside support from a regulatory specialist.
Co-Labb provided all of the written material at every stage of the application process, as well as advising on specifics of the clinical trial designs. We partnered with Dr Angela Johnson, a regulatory consultant with a wealth of experience in the IND pathway. Dr Johnson provided expert advice on the practicalities and specifics of the application. Co-Labb will liaise with the FDA at the appropriate meetings and continue to provide consultation and written content throughout BHI’s regulatory journey.
"Blue Horizon International has been extremely thrilled with the services provided by Co-Labb. Their extensive knowledge and exemplary scientific writing skills have assisted our organization in moving rapidly forward through FDA IND submissions. Co-Labb's research and thoroughness is the best in the industry and their commitment to meeting deadlines makes them indispensable to our company's success."
Blue Horizon International
> Partnership with an expert regulatory consultant
> Necessary written components of the Pre-IND application including the FDA Request Letter and the INitial Targeted Engagement for Regulatory Advice on CBER ProducTs (INTERACT) booklet.
> Planned attendance at the INTERACT meeting
> Consultation and advice regarding the trial design.
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