CMC Consulting

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 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.

CMC Consulting Services

Chemical Development

The Rondaxe team of development experts has unparalleled synthetic organic chemistry expertise.  We work assisting early stage companies manufacturing early phase clinical supplies to 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.


  • Synthetic Route Selection
  • Regulatory Starting Material Definition
  • IPC & PAT Method Development Strategy
  • pGTI (Potential Genotoxic Impurities) review
  • Analytical Strategy Development
  • Report Documentation


  • Chemistry appropriate for your stage of development
  • Access to our highly experienced industry team

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.


  • Formulation Development
  • Excipients/Ingredient Selection
  • Drug Product Analytical Methods Development
  • Analytical Strategy Development
  • Report Documentation


  • Solutions for all aspects of your development needs
  • Access to our highly experienced industry team

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™ EstiDATA™ software system and database, will help you uncover, analyze and in many cases reduce your real costs of API and Drug Product manufacturing.

For synthetic APIs, 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.

For biologically produced APIs (large molecules and secondary metabolites), we consider the process provided or a feasible process model derived from literature using our specialized BIoModule.

For drug products, we consider the formulation provided or use a formula from published regulatory documents to estimate the cost of making the product form(s).  Packaging costs in any trade dress can be estimated, including the cost of serialization.


Rondaxe’s Three Levels of Cost Analysis Services

  1. Cost estimate of API or Drug Product by a single process with basic background information and discussion of the basis of the estimate
  2. Cost estimate of API or Drug Product with a discussion of a process, consideration of alternative processes, including background information and discussion of the basis of the estimate with supporting tables and graphs
  3. Cost estimate of API or Drug product 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 processes
  • Analysis of specific manufacturing and equipment requirements for material development and production
  • Identify starting material supply costs and sourcing challenges
  • “Make vs. Buy” Critical Analysis
  • Geographic location variables in manufacturing (global analysis)
  • Guidance on most cost effective process for desired production volume
  • Focus on “Cost Drivers” (appropriate development efforts to drive down overall costs)
  • Provide a comprehensive understanding of final API or Drug Product cost estimates


  • 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.


  • 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


  • 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


  • Prevention of Compliance issues
  • Maintain GMP Compliance
  • Cost Effectiveness
  • Efficient preparation for regulatory agency inspection
  • Post-inspection Rapid Response and Remediation

Process Research & Development

Rondaxe is your world-class process research & development consulting resource. We are dedicated to helping you advancing your drug from clinical candidate selection through commercial success, and help you work with laboratory research teams identified as best fit for your specific project needs. Labs we recommend are organized and managed by experienced analytical and process development chemists and pharmacists to tackle questions that can only be answered by experiment. Moreover, drawing on the experience of our project managers and the consulting expertise at Rondaxe, we’ll make sure the right experiments are done and the correct conclusions drawn from the results.

Your project will follow a well-defined and effective road map, with emphasis on open and consistent communication. Our structured approach to project management delivers efficient and timely monitoring of scientific progress, coupled with tight tracking of both project cost and scope.

Rondaxe scientists and professionals can supplement the experience and efforts of your own development group, or fulfill all the roles of a complete process and analytical development group many of today’s virtual companies (and other smaller companies) require.


API Process Research and Development

  • Route evaluation and selection
    • Expert review of existing routes
    • Novel routes suggested by process experts
    • Rigorous evaluation of cost of goods using proprietary Rondaxe CoGsTM software
    • Laboratory evaluation of strongest candidate route(s) and route scouting procedures
    • Devise novel synthetic and fermentation technologies to achieve your manufacturing goals and build IP
  • Develop processes that operate robustly and safely at scale, ensuring security of supply
  • Develop robust and appropriate analytical methods to minimize scale-up and quality issues
  • Identify, develop and implement cost reduction strategies for existing API syntheses
  • Rapid resolution of scale up issues to avoid costly delays in compound supply
  • Salt selection studies and physical form control

Drug Product Research & Development

  • Evaluation of formulation options
    • Determination of goals of drug product form
    • Formulation options suggested by pharmacy experts
    • Experimental evaluation of strongest options
  • Solve formulation problems with a designed experimental program created by our experts
  • Work out placebo and comparator issues

Quality by Design (QbD)

  • Expertise in design and execution of critical process parameter analysis and experimental plans consistent with Quality by Design concepts
  • Establish proven acceptable ranges of operation
  • Statistical experimental design (DoE) and focused stress tests to improve weaker synthetic steps

Test Article Synthesis

  • Prepare small quantities of API to supply material suitable for use in a GLP non-clinical safety study
  • Analyze the material by scientifically sound methods and provide Certificate of Analysis

Method Development

  • Develop robust analytical methods for API, drug product, stability analysis, in-process controls, and


  • Identify and select project-appropriate laboratories to conduct experiments
  • Select scientists and teams fit-to-purpose and based on experience and expertise
  • All intellectual property (IP) belongs to the client


Our analytical development team has comprehensive methods development and validation experience.


  • Analytical Strategy Development
  • Analytical Testing/Validation Strategy
  • IPC & PAT Method Development
  • Drug Product Analytical Methods Development
  • Report Documentation


  • 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.


  • 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


  • 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.


  • 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


  • 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


  • 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