Verta Life Sciences help clients select their Contract Manufacturing Organizations using a structured selection process

cmo
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
syringes