Regulatory Documentation Collection
Our experts provide streamlined regulatory document collection and reduce the startup timeline by providing clear instructions and expectations on how to correctly complete documents and ensure a timely submission. We provide a myriad of regulatory support functions, both in the provision of applications and reports to country-specific Health Authorities and Ethics Committees, and the submission of clinical site Essential Documents on behalf of the sponsor.
|Ethics Committee Application|
|Competent Drug Authority Application|
|Pharmacy & Poisons Boards|
|National Science Committees|
ACE Research can review and evaluate your clinical data and essential site documents, provide support and prepare materials for Drug Authority meetings, maintain your master files, and as always, provide our expert advice.
Drug Authority Documents
|New drug application|
|Premarket Approval Process and Documentation|
|Premarket Approval (PMA) / Product Development Protocol (PDP)|
|Investigation Product (IP) application amendments|