We take the hard work out of regulatory submissions by taking your raw data and transforming it into the appropriate file types that are required by the Competent Authorities. From R&D to Manufacturing through to Distribution, Sales & Marketing personnel, we can liaise with your team to collate the relevant data and create your medicinal product application.
Expert Report Writing
Our cross-functional team can provide you with the complete solution, from due diligence reviews to Expert Report writing, we can provide you with the required documents you need to gain approval.
The criteria for electronic submissions globally are changing. We continually monitor developments ensuring we are at the forefront of the latest electronic submission requirements. We can build and validate your application in eCTD or NeeS format depending on your requirements. We submit our applications via CESP or other Competent Authority portals to ensure courier costs are maintained as low as possible for you.
We have ample experience of all variation types. We can manage your procedure efficiently – whether it is an MRP/DCP, Centralised or a National procedure. We will guide you through the classification process and advise you on the appropriate regulatory strategy – ensuring your application is successful. We will stay with you all the way, and project manage each application to the end.
We’re here to close the gap. We identify the gaps between your registered details and current ways of manufacturing, record the outcomes and identify the tasks that you need to do, to close this gap. Once we have agreed the remediation strategy with you, we can create the relevant product applications and close that gap efficiently and with ease.