BUILD YOUR RESILIENCE™
Custom plans, based on a well-vetted gap assessment, ready to deploy on your terms
Think of Build Your Resilience™ as your trusted secondary supplier risk reducer with Process Characterization (PC) + Process Performance Qualification (PPQ) protocols locked in and on-demand Regulatory Consultation Access. The kicker? You are in the driver’s seat of your program with three different levels of readiness that span across access to our procurement, logistic, commercial, and quality teams and programs with no annual commitment required.
Personalized, secondary supplier services
Areas of Engagement
- Late-phase/commercial programs
- Drug substance and drug product
- Biologics, vaccines, nucleic acids, cell therapy, and gene therapy
Ways to Build Your Resilience™
Procurement
- Secured secondary source
- Identified vendors
- MSA in place
- Supply secured
- Term flexibility and agreement structure
Logistics
- Raw material vendor qualification
- Materials on hand
- Methods transfer complete
Commercial
- Registration/validation batches for filing
- Regulatory filing support
- Line extension support
Quality
- QA agreement
- Maintained product/program records
- Lifecycle management
- Up-to-date inspections
Other Good Stuff
- No annual commitment
- Network of North American clinical and commercial GMP manufacturing sites including four commercially licensed facilities
- We hold a unique industry sweet spot: big enough to partner on your boldest projects, but small enough to provide the kind of service and agility that you wouldn’t typically expect from a conventional CDMO
ELIMINATE SUPPLY CHAIN NIGHTMARES
Let’s connect and talk more about what’s driving your needs, objectives, and project dynamics.
