Regulatory Affairs

Regulatory Affairs 2018-10-11T17:44:17+00:00

DP Clinical draws on its valuable experience in planning and managing essential document submissions in order to move projects forward. We understand the importance of meeting tight timelines and rely on our regulatory and therapeutic experience as well as our site and Institutional Review Board/Ethics Committee relationships to ensure studies are started as quickly as possible and maintain regulatory compliance through completion.

DP Clinical has successfully supported global sponsors with their regulatory filings for drugs, biologics, and devices. We have established relationships with Institutional Review Boards – that will help expedite study startup, and our team’s expertise will help you successfully navigate global regulatory requirements to ensure study compliance.

Our Regulatory Affairs team offers sponsors a wide array of services, including:

  • Recruitment and subject information materials preparation
  • Informed Consent Form development
  • Vendor qualification
  • Advertising and promotional materials preparation
  • Maintenance of documentation and records review
  • Obtaining certified translations in various languages