Pharmaceutical Industry Consulting
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