eCTD System Implementation

The responsibility of deploying a new eCTD publishing system or upgrading an existing system can prove exciting, challenging and even overwhelming depending on the resources available to execute such an assignment. We, at PEC, realize that system implementation is much more than installing a suite of tools or software. Our practical and hands-on experience represents over a decade of knowledge gained from working in the industry. We possess a good understanding of the daily tasks and standard processes that a Regulatory Department may encounter regardless of organizational size and/or budget. We are adept at customizing any plan to meet the unique needs of our clients. Let our eCTD implementation consultants' partner with you to successfully plan out and execute all of the inter-related tasks to achieve your desired results.

Our core activities in an implementation can be tailored to:

  • Assist in the determination of scope and creation of Project plan
  • Analyse user needs and write User Requirement Specification
  • Write Request for Proposal
  • Facilitate communication with potential software vendors
  • Participate in vendor selection process
  • Arrange and participate in Project/Management meetings
  • Advice in the selection of the right tool for your company and your requirements
  • Gap analysis
  • Write validation documentation
  • Describe and document the procedures surrounding the system
  • Train regulatory employees

Please contact us at contact@pec-services.com to learn how Pharmaceutical eConsulting can start helping you today and in the future.