The Red Nucleus Difference
It’s not what we do; It’s HOW we do it…
Flexible Service Model
Red Nucleus understands that one size does not fit all and can conform our processes to meet client specific needs. Red Nucleus has efficient internal processes that enable very quick turnaround times, in many cases same-day or next day, providing clients with a competitive advantage.
Strategic Partnership
A remote team that functions as a cohesive extension of your internal team. Strong collaboration, coordination, and subject matter expertise to drive your business processes and objectives.
Drug Development & Submissions
Red Nucleus understands the content of the submissions and does not rely on the client to explain the documents or lifecycle for the submission. Red Nucleus interprets the documents, publishes them and submits them.
How We Integrate with Your Organization
| Pre-Commercial Clients developing First Product(s) | Clients dealing with Growth/Change | Clients with Common Challenges or Unique Needs |
|---|---|---|
| FDA meeting package prep | Business Process Refinement, SOPs, and Training to support change and compliance | Label Management |
| Submission templates | RIM vendor RFP/Selection process | Publishing Overflow – various options |
| Content granularity guidance | System Implementation support | Publishing Business Continuity |
| Medical Writing & Authoring | IDMP assessment/planning/rescue | Process Change/Optimization |
| Document formatting/QC | Label Management - Proactively | Training/eLearning to support any/all process change |
| Full publishing and eCTD (including formatting/QC) | “Rescue” of projects: IDMP & RIM implementations | |
| Content repository for use | ||
| Archive Vault for use | ||
| Business Process Definition, SOPs, and Training | ||
| Compliance Training | ||
| Inspection Readiness |