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:
- 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
- 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
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