Rondaxe CMC consulting group specializing in pharmaceutical consulting. We focus on consulting for the pharma sector, 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 managers 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.
Chemical Development
The Rondaxe team of pharmaceutical CMCdevelopment experts has unparalleled synthetic organic chemistry expertise. We work assisting early stage companies manufacturing early phase clinical supplies, such as pharmaceutical drug research and development, to process development, such as setting commercial scale processes and operations for late stage or commercial products. Our team has developed chemistry and launched multiple pharmaceutical products. We work on technical transfers, DoE, validation, and manufacturing oversight.
Drug Product Development
Our drug product team has wide experience in formulation process development, scale up, and commercialization of sterile, oral solid, ophthalmic, topical and veterinary products.
Services
- Formulation Development
- Excipients/Ingredient Selection
- Drug Product Analytical Methods Development
- Analytical Strategy Development
- Report Documentation
Benefits
- Solutions for all aspects of your development needs
- Access to our highly experienced industry team
API Manufacturing Cost Estimates & Cost of Goods Analysis
The real costs of manufacturing in the pharmaceutical industry are difficult to determine. Our industry-experienced professionals, utilizing Rondaxe’s proprietary [Re]source™ CoGs™ software system and database, will help you uncover, analyze and in many cases reduce your real costs of API manufacturing. Our analysis includes: a thorough literature search, patent inquiry, analysis of synthetic routes and yields, starting material analysis, manufacturing facility and/or specialized processing requirements, labor requirements, etc. We’ll prepare a detailed manufacturing cost estimate that along with the essentials above will include detailed consultation and discussion on the challenges inherent in the identified routes, material options and the anticipated cost of the final API/intermediate.
Services
Rondaxe’s Three Levels of Cost Analysis Services
- Cost estimate of API for a single synthetic route with basic background information and discussion of the basis of the estimate
- Cost estimate of API with a discussion of synthetic route, consideration of alternative routes, including background information and discussion of the basis of the estimate with supporting tables and graphs
- Cost estimate of API with a detailed discussion of the estimate, slides for a presentation, and research into specific issues. (Requires an in-depth discussion with client to mutually agree on all deliverables.)
We provide access to the [Re]source™ cost model(s) through a Rondaxe provided web portal for client-driven “what-if” analyses of the impact of yield efficiency, throughput, and key material prices.
Cost Analysis Benefits
- Understand the challenges of selected synthetic routes
- Analysis of specific manufacturing and equipment requirements for material development and production
- Starting materials costs and sourcing challenges
- “Make vs. Buy” Critical Analysis (material costs versus manufacturing costs)
- Geographic location variables in manufacturing (global analysis)
- Guidance on most cost effective synthetic route for desired production volume
- Focus on “Cost Drivers” (appropriate development efforts to drive down overall costs)
- Provide a comprehensive understanding of final API cost estimates
Clients
- Established Pharmaceutical Companies
- Emerging Pharmaceutical & Biotech Companies
- API Sourcing Professionals
- Generic API Manufacturers
Quality Assurance
The Rondaxe Quality Team is focused on providing the highest level of cGMP Quality Assurance for all stages of development and manufacturing. Our quality team is made of pharmaceutical industry professionals with years of industry experience. Our team is experienced in API and Drug Product cGMP compliance for both small and large molecules, and also medical device cGMP. We have strong technical skills in aseptic processing and sterile products manufacturing, and we bring you extensive experience in analytical chemistry and microbiology laboratory operations.
Services
- Prepare and manage required SOPs for cGMP compliance
- Train staff in cGMP policies and compliance
- Prepare and execute Quality Agreements with contract manufacturers (CMOs/CDMOs)
- Serve as the Release Authority on behalf of the client
cGMP Auditing
- Assess and consult on level of compliance of manufacturers
- Provide written gap analysis
- Propose compliance improvement opportunities
cGMP Remediation & Compliance Improvement
Rondaxe works directly with the manufacturer’s quality unit to implement improvement programs:
- Define required CAPA
- Establish missing or incomplete quality systems
- Prepare needed SOPs
- Train both manufacturing and quality unit staff
Manufacturing Operations
- Review and recommend opportunities for improvement of batch records and other operations documentation to improve shop floor and QA release efficiency
- Advise on suitability of facilities for API, large molecule and sterile product manufacturing to ensure GMP compliance
- Advise on design and operation of environmental monitoring systems for “clean rooms” and other controlled manufacturing facilities
- Provide an organizational strategy for conducting and reporting sterility failure investigations to assess root cause and define corrective action and preventative actions
Validation
- Help create the critical process parameter analysis experimental plan to be consistent with Quality
by Design (QbD) concepts - Draft the process validation protocol to be consistent with QbD concepts
- Help organize the process validation plan or validation data
Preparation for Agency Inspection (FDA PAI)
Train Quality staff to manage a regulatory authority inspection, including:
- Assist in selection of subject matter experts (SME)
- Train SMEs on proper procedures for responding to investigator questions
- Set up documentation “war room”
- Ensure all previously identified CAPA are complete
- Perform final housekeeping inspection to ensure a facility is fully prepared
- Organize daily de-briefing and assignment of follow-up duties
- Advise on response to all inspection observations
Benefits
- Prevention of Compliance issues
- Maintain GMP Compliance
- Cost Effectiveness
- Efficient preparation for regulatory agency inspection
- Post-inspection Rapid Response and Remediation
Analytical
Our analytical development team has comprehensive methods development and validation experience.
Services
- Analytical Strategy Development
- Analytical Testing/Validation Strategy
- IPC & PAT Method Development
- Drug Product Analytical Methods Development
- Report Documentation
Benefits
- Stage appropriate Analytical strategies
- Access to our highly experienced industry team
Supply Chain & Manufacturing Strategy
Rondaxe can assist with overall strategy, implementation and on-going supply chain management. Our experts in API (Active Pharmaceutical Ingredient) and Drug Product manufacturing will guide your company through all business aspects that could impact your supply chain, including manufacturing planning, raw material sourcing, materials planning, vendor selection, cost of goods, inventory planning, and supply redundancies and integrity. Rondaxe prepares you for launch, helps brings new manufacturing facilities online and your new products to market.
Services
- End-to-end Supply Chain Assessment and Optimization
- Technology Transfer Planning and Management
- Vendor Selection
- Vendor Audits and Management
- Cost of Goods Evaluation
- Inventory and Contingency Strategy
Benefits
- Fully Optimized Supply Chain
- Reduced Costs throughout the Supply Chain and to Final Product
- Improved Vendor Quality, Reliability and Integrity
- Contingency Planning and Supply Chain Redundancy
Bio & Fermentation Development
The Rondaxe team of development experts has experience in every aspect of the industry. In addition to small molecule drug substance development, Rondaxe has extensive experience in biological and cell culture technologies, including cell line engineering and recombinant protein expression and biotransformation. Our drug product team has wide experience in formulation process development, scale up, and commercialization of sterile, oral solid, ophthalmic, topical and veterinary products. Our analytical development team has comprehensive methods development and validation experience.
Services
- Synthetic Route Strategy Development
- Synthetic Route Selection
- Regulatory Starting Material Definition
- IPC & PAT Method Development
- Strain Selection
- Feed and Media Optimization
- Protein Fermentation & Purification
- Biocatalysis Strategy Development
- Analytical Strategy Development
- Analytical Testing/Validation
- Formulation Development
- Excipients/Ingredient Selection
- Drug Product Analytical Methods Development
- Report Documentation
Benefits
- Solutions for all aspects of your development needs
- Access to our highly experienced industry team
Regulatory Affairs
In a new biopharmaceutical regulatory era of FDASIA, breakthrough therapy (BT) designations, and evolving policy on the one hand, and a continuing lack of international harmonization and regulatory standardization in global markets on the other, sound regulatory advice has never been more essential.
Gain full access to Rondaxe industry experts in all areas of CMC (Chemistry, Manufacturing & Controls) regulatory consulting services. Let us assist with manufacturing & supply chain issues, regulatory strategy planning, and the preparation of regulatory documents and applications. Rondaxe will ensure you know what you need to know for all regulatory compliance.
Regulatory Strategy
- Advice on developmental, manufacturing, analytical, and supply chain issues, including registered starting material (RSM) selection and change control
- Full identification and documentation on supply chain
- Assembly of CMC sections of INDs and NDAs
- Preparation of DMFs
Benefits
- Access to top level industry experts
- Efficient resolution to regulatory issues
- Regulatory Strategy for starting material designation (RSM)
- Regulatory Strategy for organization
- Streamline regulatory filings
- Preparation of IND, DMF, NDA documents for regulatory filings
