Our Services

At Coswald Consulting, we offer a variety of services to meet your pharmaceutical development, quality and manufacturing needs, including:

• Oligonucleotide quality and manufacturing background (CMO environment)
  
  • Process improvement/characterization
    
  • Engineering/plant design/recommendations
    
  • Development/scale-up/NPI
    
• CMO and large pharma quality control experience
  
• Biopharmaceutical CMC writing, assistance, and development
  
• Extensive technical writing (oligonucleotide, biologic, biosimilar) and review - batch records, processing and quality non-conformances, change control evaluation/implementation, validation reports, etc.
  
• Experience with pre-clinical through pre-commercial biologic and oligonucleotide therapeutic development
  
• Extensive quality and production experience, including line management of large departments (QC and MFG)
  
• Regulatory understanding and application - QRM, Quality by design, etc.
  
• FMEA exposure and understanding, risk assessment application
  
• Pre-approval inspection understanding and preparation
  
• Process validation/characterization