StartingPoint submission authoring suite

Creation and management of dossier plans and submission packages aligned to regulatory strategy, providing guidance across drug development to support timely, compliant submissions through coordinated cross-functional collaboration.

Prepares eCTD content for submission through Word formatting, bookmarking, and hyperlinking, supporting clinical, safety, regulatory, CMC, and eCRF documents while ensuring readiness in line with regulatory guidelines.

Supports filings to global health authorities across development, approval, and post‑approval phases in eCTD, CTD, and NeeS formats using compliant publishing tools aligned with regional and ICH standards.

Supports pharmaceutical and biotech companies in maintaining registered dossiers to meet country‑ and region‑specific requirements across the product lifecycle, including annual reports, renewals, supplements, variations, and line extensions.

Expedites regulatory dossier development with clear, structured scientific and medical documents, concise messaging, and factual content that meet regulator and medical community expectations.

Delivers regulatory strategy, submission management, guideline interpretation, compliance support, and acts as U.S. Agent by handling FDA interactions, application review, regulatory writing, and agency communication.

Delivers product labeling and change control, including SPL conversions and updates, registrations, NDC management, and health authority submissions, while managing CCDS and safety labeling updates across global lifecycle requirements.