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