Regulatory Strategy and Planning Services

Synterex can take so much of the strategy and planning burden off your team's shoulders. Whether it's communication with regulatory authorities, planning and conducting meetings, or the hands-on work of the publishing process, we have the experience you need. Take a look at all the ways we can help.

Strategy and Planning

  • Kickoff meeting leadership (submissions and individual documents)
  • Meeting coordination
  • Coordinating document stakeholder input (eg, legal review)
  • Support for critical FDA communications/responses
  • Consulting for expedited approval pathways and designations
  • Regulatory CMC consulting
  • Consulting on clinical development plans
  • Interpretation of regulatory guidance and advising on disease- or topic-specific guidance
  • Preparation for regulatory interactions
  • Regulatory intelligence

Operations

  • Formatting Word documents
  • PDF rendering
  • Prepublishing (eg, bookmarking, linking)
  • Electronic submission through ESG and gateway configuration
  • eCTD viewer training and on-site support
  • Product family/metadata setup and lifecycle maintenance of serial submissions
  • Submission meeting leadership, including development of and updates to submission content plans
  • Submission tracking and archiving
  • Regulatory operations documentation support: cover letters, LOAs, IND number requests, FDA forms, FDA telephone contact forms
  • eCopy submissions
  • DMF submissions
  • StartingPoint training and customization; product maintenance/upgrades and rollout in collaboration with IT
  • Coordinating expedited safety reporting process with CRO and client
  • Printing, binding, and shipment services for desk copies/non-eCTD submissions
  • Scanning for legacy submissions

Looking for something else? See our other areas of expertise: