Regulatory Operations

EXPERIENCE & QUALITY

Our team has significant experience in regulatory publishing and has a successful track record with various types of projects including but not limited to:

  • INDs and CTAs at all stages of development

  • BLAs

  • Amendments

  • Master Files

  • DSURs

  • Protocols, Informed Consents, Investigator's Brochures

  • Agency Briefing Packages

We pride ourselves on delivering only the highest quality publishing for our clients.  It is not required to utilize other HCI services to take advantage of our Regulatory Operations services.  HCI Regulatory Operations services are national and international, can be combined with other aforementioned HCI expertise and services, and can be exclusive or non-exclusive. HCI may also serve as a US agent for non-US clients.

EXAMPLES OF REGULATORY OPERATIONS SERVICES

  • Standard and Custom Word Templates

  • Publishing of Word and PDF documents and associated linking

  • eCTD compilation

  • Submission through ESG (Electronic Submission Gateway)

Regulatory Operations may also provide other services for other types of publishing needs that may not be regulatory submission related, such as:

  • creation & publishing of presentations

  • summaries

  • articles

  • guides

  • business proposals

We work closely with our clients to build and achieve the needs of each project as well as establish clear goals and timelines to optimize success.