SRSC

Services

Regulatory Submission Planning, Management, & Implementation

Author, Edit, Critical Review of Clinical Regulatory Documents

Author, Edit, Critical Review of Clinical Regulatory Documents

Message identification, refinement, alignment (within and across documents, phases of development, and audiences) with target product profile and corporate goals

Identify resource requirements, resources, processes, standards, regulatory agency expectations and guidelines

Author, Edit, Critical Review of Clinical Regulatory Documents

Author, Edit, Critical Review of Clinical Regulatory Documents

Author, Edit, Critical Review of Clinical Regulatory Documents

INDs, protocols, IBs, and CSRs

Regulatory briefing documents and marketing applications (e.g., BLAs, MAAs, NDAs)

Publications and white papers

Additional Services

Author, Edit, Critical Review of Clinical Regulatory Documents

Additional Services

Independent QC review of documents, document formatting, and PDF publishing

Training on audience-centered writing and review practices, including the importance of having an integrated communication strategy throughout product lifecycle

Development and review of document templates (e.g., protocols, CSRs, etc.)

Oversight and/or coordination of writing staff