The ClinDatrix Regulatory Affairs team provides regulatory services to clients across the full range of the clinical project life cycle for pharmaceuticals and medical devices. Our approach is based on an in-depth understanding of each client’s project; a strategic analysis of the appropriate regulatory needs; advanced planning to meet timelines; and strong execution of regulatory filings, agency communications and compliance with regulations.
Services range from a simple advisory capacity, to full IND, NDA and IDE preparation and submission. Our Regulatory team provides broad experience, including project management, FDA regulatory filings and communication, and regulatory operations management and execution. Highly experienced members of other ClinDatrix departments, including Clinical, Medical Safety, Data Management, Biostatistics and Project Management are available to assist as appropriate, completing a fully functional clinical development team to ensure successful product registration.
Regulatory Submissions
We prepare, compile and submit FDA submissions in paper or electronic formats. This includes annual reports, supplemental submissions, DMF, pre-IND briefing documents, INDs, NDAs, premarket approval applications (PMAs) and pre-IDE and IDE and 501(k) submissions for medical devices.
Administrative Support
Our services also include tracking of submissions documents, timeline and resource management, interpretation of ICH/FDA/EMA guidelines and development of business processes and SOPs.