What We Do
Regulatory Strategy
If you are looking for a development activity timeline from IND to marketing approval or a more limited or focused strategy plan, we have the experience and expertise to develop and maintain the strategy plan.
Document Review and Preparation
We can prepare your submission documents for you, or we can serve as an extra review to ensure your documents meet regulatory requirements and expectations. We can also work with your team on internal QA documents.
Audits and Inspections
We specialize in challenging and “for cause” audits but can also assist in handling your routine audit needs. We are here to work with your team and your service providers to prepare for FDA inspections.
FDA Meetings and Communication
We have extensive experience in achieving successful outcomes in communicating with the FDA. We can prepare your meeting requests, briefing materials, and lead your FDA meetings.
US Agent for Foreign Entities
We can facilitate your interactions with FDA by serving as your US Agent. We will review your submissions to ensure they meet US requirements. We also serve as sponsor representtive for domestic firms that do not have in-house regulatory or who are inexperienced in working with FDA.
In-house and Virtual Training
We offer on-site and virtual training in Regulatory affairs, clinical operations, and quality Assurance. We also provide focused training to meet your specific company needs.