Create an account
Logo Coswald Consulting Llc

Coswald Consulting Llc

Address: ADRESA to be completed

Send an enquiry
Profile Image Coswald Consulting Llc
Logo Coswald Consulting Llc

Coswald Consulting Llc

(9 reviews)

Biopharmaceutical Production and Quality Professional - Oligonucleotide MFG and Development

About Coswald Consulting Llc

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)
Login And Write Your Review

Write Your Reviews

Writing great reviews may help others discover the places that are just apt for them. Here are a few tips to write a good review:

3 Star
Be the First One To Review This Listing!!!

Company Info

  • Year Founded 2015
  • Number of Employees Under 49
  • Minimal Budget Under $1,000
Help & Support

What service do you need? DokaLink will help you

Add your business

#1 Business Directory and Service Provider

Find the Best Qualified B2B Service Providers for Your Business

© 2020 DokaLink All rights reserved.