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Senior level consulting group 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.
Product Development
Research Development
Chemical Development
Fermentationt
Analytical
Regulatory
Quality
Strategy
Chain
Drug Product Development
- Formulation Development
- Excipient/Ingredient Selection
- Analytical Methods Development
- Report Documentation
Process Research & Development
- Cost effective bench scale laboratory research of process ideas
- Explore alternative synthetic routes
- Assess economic and regulatory impact of findings
- Reduce costs and time to filing
- Improve product quality and robustness of the process
Chemical Development
- Synthetic Route Strategy Development
- Synthetic Route Selection
- Regulatory Starting Material Definition
- IPC & PAT Method Development
Fermentation & Biocatalysis Development
- Strain Selection
- Feed and media optimization
- Protein Fermentation & Purification
- Biocatalysis Strategy Development
Regulatory
- Regulatory Compliance Gap Analysis of product development plans and Submissions
- Regulatory Evaluation and Strategy
- Participate in FDA review meetings
- Prepare regulatory filings
Quality
- cGMP Auditing
- Stability Assessment/Program Design/Implementation
- Vendor Audits
- Pre-Approval Inspection Preparation
- cGMP Remediation
Manufacturing Strategy
- Manufacturing Strategy
- Manufacturing Process Development and Validation
- Process Assessment and Optimization
- Manufacturing Scale-Up
- Technology Transfer
Supply Chain
- Technology Transfer Planning and Management
- Vendor Selection
- Vendor Audits
- Cost of Goods Evaluation
Benefits
- A team that is strategic, but hands on throughout the entire project based on your needs. We can seamlessly become part of a client’s virtual team. Provide advice and counsel, or do the work for you with full implementation and execution capabilities.
- Proprietary systems that keep the process on track allowing our clients complete control and stewardship of their projects from big picture overviews to the smallest of details.
- Flexibility to begin or end anywhere along the development path to fit your specific needs.
- A dedicated Project Manager with extensive industry knowledge who serves as the one point of contact to the broader multi-discipline team.
- Facilitate training and broaden the experience for a client’s staff.