Contract Service Directory


Jubilant HollisterStier CMO





Company Headquarters

3525 North Regal Street,
Spokane, WA 99207
United States

Company Description


 
 
Vital Statistics

Year Founded: 1921

Number of Employees: 800+

Key Personnel: Spokane, WA; Montreal, Quebec



Who we are

Jubilant HollisterStier is an integrated contract manufacturer of sterile injectables, ophthalmics, otics and sterile and non-sterile topicals and liquids. Our facilities in North America provide specialized manufacturing services for the pharmaceutical and biopharmaceutical industries. We provide a full-range of support and services to streamline the manufacturing process such as on-site assistance from process qualifications through product release.



Facilities

Sterile Injectable Fill/Finish - Spokane & Montreal
Sterile liquid fill/finish into vials and ampoules, clinical to commercial, lyophilization

Sterile Ophthalmics & Otics - Montreal
Solutions & suspensions, ointments, computerized batching, CIP/SIP system, plastic and laminate tubes

Non-Sterile Topicals & Liquids - Montreal
Gels, liquids, ointments and solutions filled into bottles, tubes, and pumps. Gravity fed filling, oxygen, heat and light senstitive products
 

Services Offered

Fill/Finishing

  • Process Development
  • Inspection
  • Compounding Aseptic Compounding
  • Labeling
  • Filling
  • Packaging
  • Lyophilization
  • Multiple Storage Conditions
  • Terminal Sterilization
  • Vendor Qualification

 

Analytical and Microbiological

  • Stability Storage and Testing (ICH Standards)
  • Method Validation
  • Qualification of analytical methods
  • Finished Product and Raw Materials Testing
  • Technical transfer of methods
  • High Performance & Ultra High Liquid Performance Chromatography (HPLC & ULPC)
  • Sterility Testing
  • Biological Assays

 

Validation

  • Process Validation
  • Project Master Plans
  • Operational Qualification
  • Performance Qualification
  • Protocol Writing and Summary Reports
  • Component Evaluation
  • Project Management Summary
  • Installation Qualification

 

Regulatory

  • Regulatory Strategy Formulation
  • Effective Facilitation of Interaction with Regulatory Authorities
  • Guidance and Expert Review of Regulatory Submissions
  • Prepare and Supply a Complete Range of Regulatory Documents
  • Drug Master File
  • Electronic Submissions (eCTD)
  • FDA (CDER, CBER), EMA, PMDA, ANVISA, Health Canada

 

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