As the channel of communication to the regulatory authorities, the role of RA is to anticipate the requests and requirements from regulators and to accurately interpret regulations and guidance to ensure these requests and requirements are adequately fulfilled. We address these business needs with compliant and well-crafted submissions and assist our clients to negotiate and communicate with the regulatory authorities.
Our Approach
RegDev partners with you to seamlessly integrate with your project teams and provide strategic guidance and leadership to help you navigate the ever-evolving regulatory landscape. Our consultants are seasoned regulatory professionals who will work with your team members at all levels, as well as your vendors and the regulatory authorities. Our team prepares you for marketing approval, IND clearance and NDA/BLA support, agency interactions, special requests for beneficial regulatory designations, document review, and regulatory oversight.
RegDev provides strategic and technical advice to drive early and late-stage development and marketing of compounds, while ensuring compliance with legislative requirements and guidance from regulators. Our consultants focus on making sure that your business’s needs are fulfilled successfully. We advise on development and approval pathways, accelerated programs, manufacturing, testing, validation, and global programs.
REGULATORY STRATEGY
SEAMLESS TEAM INTEGRATION
EARLY AND LATE- STAGE SUPPORT
CHANNEL OF COMMUNICATION
PROACTIVE-STRATEGIC PLANNING
REGULATORY LANDSCAPE NAVIGATION
STRATEGIC REGULATORY PLANNING
We help clients strategically plan global regulatory agency interactions, including briefing document development for milestone meetings, strategic crafting of questions, and content-by-design to secure the desired outcomes. We can provide strategic input on approval pathways, regulatory filings, and the regulatory landscape.
RAPID, SEAMLESS TEAM INTEGRATION
We can provide plug-and-play support to fill specific needs, or fully integrate within established project teams. Our expertise allows our consultants to onboard quickly to provide immediate input and positive impact.
PRIDE IN YOUR PRODUCT
We take pride in your projects and work product as if we were your permanent employees. Our goal is to help you navigate the ever-evolving regulatory landscape for your therapeutic area, advise on the path to milestones, and help your business make a positive impact on the lives of patients and their families.
Team Member Quote
“I derive satisfaction when opportunities present themselves to potentially make a difference in patients’ lives. It is very motivating to be part of an invested team and to assist in helping emerging and mid-sized companies to define their regulatory strategies for the multiple aspects of an overall development program.”
