SERVICES

Home  >>  SERVICES

Pharmaceutical Industry Consulting

Experienced in working with a wide variety of products

Experienced in working with a wide variety of products

  • Formulation Development
    • Solid Dosage Forms – tablets, capsules, powders, immediate release, controlled release, bioavailability improvement
    • Oral Liquid Dosage Forms – solutions, suspensions, preservation, flavour modification
    • Nasal Sprays – solutions, suspensions, preservation, preservative-free, flavour modification, devices
    • Parenteral Solutions – intravenous, intramuscular, subcutaneous
  • Manufacturing Process Development & Optimization
    • Critical Process Parameters
    • Process Analytical Technology (PAT)
    • Validation and Process Performance Monitoring
  • Project Management
    • Chemistry, Manufacturing and Controls (CMC) relating to Pre-clinical studies and Clinical Phases I – III
    • Technology Transfer from R&D to commercial production. Inter-site process transfers.
    • Project Team Dynamics and Interdisciplinary Collaboration
  • CDMO Interface Management
    • Proposal review and contract negotiation
    • On-site supervision and liaison
  • Quality Assurance (QA) and Quality Control (QC)
    • Quality by Design (QBD)
    • Compliance Auditing in accordance with Good Manufacturing Practice (GMP) regulations including Health Canada, FDA and EU
    • Review of manufacturing and testing of products to assess GMP compliance for use in clinical trials
    • Independent CMC QA approval of products for use in clinical trials

 

For more information please contact Austin Freedman at austin@pharminstinct.com

Save

Save

Follow
Get every new post delivered to your inbox
Join millions of other followers
Powered By WPFruits.com