CMC Consulting Overview
Rondaxe CMC consulting group is focused on providing drug development and manufacturing strategies to the pharmaceutical industry, concentrating on providing services to emerging and specialty pharma companies. Rondaxe employs a diverse group of former directors, and senior directors from the pharmaceutical industry with expertise with chemical, fermentation, drug product and analytical development, supply chain strategy, manufacturing operations, quality control, quality assurance and regulatory affairs.
CMC Consulting
- CMC Consulting
- Chemical Development
Chemical Development
- Synthetic Route Strategy Development
- Synthetic Route Selection
- Regulatory Starting Material Definition
- IPC & PAT Method Development
- Fermentation & Biocatalysis Development
Fermentation & Biocatalysis Development
- Strain Selection
- Feed and Media Optimization
- Protein Fermentation & Purification
- Biocatalysis Strategy Development
- Analytical
- Regulatory
Regulatory
- Regulatory Compliance Gap Analysis
of product development plans and
Submissions - Regulatory Evaluation and Strategy
- Practice in FDA review meetings
- Prepare regulatory fillings
- Regulatory Compliance Gap Analysis
- Quality
Quality
- cGMP Auditing
- Stability Assessment/Program
Design/Implementation - Vendor Audits
- Pre-Approval Inspection Preparation
- cGMP Remediation
- Supply Chain & Manufacturing Strategy
Supply Chain & Manufacturing Strategy
- Technology Transfer Planning and
Management - Vendor Selection
- Vendor Audits
- Manufacturing Strategy
- Manufacturing Process Development
and Validation - Process Assessment and Optimization
- Manufacturing Scale-Up
- Technology Transfer
- Technology Transfer Planning and
- Cost of Goods Analysis
Cost of Goods Analysis
- API manufacturing cost estimates
- Model manufacturing processes
- Detailed cost analysis
- Analysis of technical and
cost challenges of synthetic route - Understand labor/facility costs and
raw material cost contribution - Direct your drug development efforts
to drive down cost
- Drug Product Development
Drug Product Development
- Formulation Development
- Excipient/Ingredient Selection
- Analytical Methods Development
- Report Documentation
- Process Research & Development
Process Research & Development
- Cost effective bench scale scale laboratory
research of process ideas - Explore alternative synthetic routes
- Asses economic and regulatory impact of
findings - Reduce costs and time to filing
- Improve product quality and process robustness
- Cost effective bench scale scale laboratory