Verta Life Sciences help clients select their Contract Manufacturing Organizations using a structured selection process
Supply Partner Key Attributes
With our clients we establish Supply Partner Attributes such as:
Essential attributes
- Have a can do attitude
- Ability to recruit and retain key technical staff
- An established and internationally recognized manufacturer of secondary Pharmaceutical Product
- Routinely supply finished pharmaceutical packs to multiple international markets
- Routinely supply products centrally registered with FDA & EMEA
- Experience with new product launches
- Experience managing supply chains
- Well established Quality Management System
- No significant adverse regulatory or recall incidents in the past 5 years
- Solvent business operation with no indication of business interruption or closure
- Have the expertise in house to support tech transfer and process development / optimization using quality by design principles
- Have the analytical experience in house to transfer in analytical methods and optimize these methods for routine production and potentially real time release.
- Demonstrated ability to work with virtual organizations to deliver successful clinical trials supply and launch
- Work with financial transparency
Reviews of existing supply relationships
- Contract Strategy
- Contractual Situations
- Supply Agreement Negotiation / Execution
- Pricing Review
- Cost Savings Options
- Security of Supply
- Financial stability of contractors
- Legal Support
- Key Terms
- Length of Agreements
- Assignability
- Limits of Liability
Understand existing suppliers
Example of a supply issue:
- Injectable Sterile Product
- Product supplied globally in prefilled syringes for hospital use
- Syringes found cracked following sterilization
- Product ran out of stock in many markets
- Global Rationing of supply
- Market confidence in a life saving drug being eroded
What happened?
-
Syringe manufacture changed their manufacturing process in one of their plants without telling customers:
- Process changes induced stress into the body of the syringe
- Syringes cracked during sterilization
