Coswald Consulting LLC offers service and guidance in the areas of biopharmaceutical scale-up and production, technical writing, Chemistry, Manufacturing & Controls, and process characterization / validation. Principal consultant has 20 years of pharmaceutical experience, including GMP production, quality control, and quality assurance.
Industries include: oligonucleotides, biologics, biosimilars, and cannabis sativa.
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:
• Facility Design / Process Scale-Up (for example services necessary to develop/advance oligonucleotide-based therapeutics on scales from 5 mmol to 900 mmol)
• Chemistry, Manufacturing & Controls, and process characterization (pre-PPQ and PPQ) including MOC (Materials of Construction), L&E (Leachables and Extractables), Origin of Impurities, Fate of Reagents, and Reagent Criticality supporting documents.
• Auditing of oligonucleotide drug substance and drug product production sites via ICH Q7, Q9, Q10, and Q11 and EudraLex
• Process validation - protocols, reports, readiness, gap analysis, DoE, etc.
• Person in Plant onsite representation and management of CMO activities
• Equipment recommendations / Commissioning (IQ/OQ/PQ drafting and execution) / process improvement
• Technical writing (DEVs, NCRs, CAPAs, IND, campaign summary, process development summary, process improvement technical development reports, etc.)
• FMEA / CPP & CQA Cause and Effect Risk Assessment / PAI Preparation
• New Product Introduction / Technical Transfer
• Drug Substance Process Characterization/Validation
• Pharmaceutical Analytical Method Development/Optimization
• Engineering/Establishment of Production, Quality, and Compliance Systems
• Process Modeling / PAR/NOR/CPP/CQAs
• Batch record / technical document drafting, improvement, and review (master and executed batch records)
