Delivering expert regulatory services: our regulatory team has the expertise to develop strategic regulatory plans, facilitate Agency meetings, and prepare, review, and file regulatory submissions in both the US and across Europe. Pacific Link Consulting has decades of experience in the US and European regulatory environments. Our access to highly skilled consultants and partners across the US and the EU, who maintain a knowledge of current regulatory requirements and have sustained relationships with government regulatory personnel, allows us to offer clients a comprehensive regulatory pathway.
Pacific Link Consulting can file Clinical Trial Applications (CTAs) in Canada and the US on a clients’ behalf. We can help the client obtain legal authorized representative for the region, project manage your CTA, write and prepare meeting requests as well as meeting packages.
Other markets of expertise include Japan and Europe.
Please contact us to learn more about what Pacific-Link Consulting can do for your project.
Regulatory Services US & EU