Bringing Together Strategy and Communication

SYNTEREX
SYNTEREX

Strategy

  • 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