Coswald Pharmaceutical/Biotechnology Consulting LLC
Research - Keenesburg, Colorado, United States
Coswald Pharmaceutical/Biotechnology Consulting LLC Employees
Coswald Pharmaceutical/Biotechnology Consulting LLC Details
Coswald Consulting LLC offers assistance in pharmaceutical development, including services necessary to develop/advance oligonucleotide-based therapeutics on scales from 5 mmol to 900 mmol. At Coswald Consulting, we offer a variety of services to meet your pharmaceutical development, quality and manufacturing needs from pre-clinical to pre-commercial, including: • Providing biotech consulting services particularly in the areas of nucleic acid scale-up and production, Chemistry, Manufacturing & Controls, and process validation. • Process Modeling / Understanding of PAR and NOR boundaries • Process scale up and/or improvement • Process validation - protocols, report, readiness, gap analysis, DoE, etc. • Pharmaceutical quality control and method development • FMEA/Risk assessment modeling • New product introduction/technical transfer • Pre-approval inspection (PAI) preparation • Batch record / technical document drafting, improvement, and review (master and executed batch record) • Quality and production systems implementation • Person in Plant representative for major oligonucleotide CMO site
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