Our highly qualified team of Clinical Solution’s experts provides a myriad of regulatory support functions, both in the provision of applications and reports to the FDA, and the submission of clinical site Essential Documents on behalf of the sponsor.
Clinical regulatory experts can serve as resources to create protocols that can be finalized quickly and supported by sites so that studies run on time or even ahead of schedule. We provide IND/IDE and NDA/PMA support and guide the client through each step of the process: providing expert advice, planning meetings, preparing pre-meeting briefing packages, and facilitating communication with regulatory agencies.
ClinicalRM can review and evaluate your pre-clinical data and your essential site documents, provide support and prepare materials for FDA meetings, maintain your master files, and as always, provide our expert advice.
In addition, we can submit your FDA regulatory documents, including:
• Regulatory Consulting and Assessment (gap analysis) for drug, biologic, and medical device products
• IND/IDE Regulatory Submission
• IRB Submission
• FDA and Advisory Meeting Preparation and Liaison
• NDA and 510(k) FDA Regulatory Submission
• Review of Clinical Site Essential Documents
• Preparation and Consultation of Standard Operation Procedures (SOPs)