Scientific Consulting
Scientific Guidance for Complex Questions, Projects, and Decisions
Not every scientific challenge begins with a clearly defined laboratory test.
Sometimes the first challenge is determining what needs to be investigated, what
information is missing, which scientific approach is appropriate, and how the resulting
data will support the next decision..
CMDC Labs provides scientific consulting for organizations that need experienced technical
guidance alongside laboratory testing, research, product development, troubleshooting,
validation, and quality or regulatory activities.
Our multidisciplinary team can help clients define scientific objectives, evaluate existing
information, develop testing and study strategies, select appropriate analytical approaches,
interpret scientific data, and plan complex laboratory programs.
Whether you already have a defined technical question or simply know that something needs to
be understood, CMDC Labs can help establish a scientific path forward.
CMDC Labs is
accredited under
Start With the Scientific Question
A laboratory test is most useful when it answers the right question.
Before testing begins, organizations may need to determine:
- What are we actually trying to understand?
- What decision will the resulting data support?
- What information is already available?
- What information is missing?
- Which hypotheses should be investigated?
- Which samples, controls, or comparison materials are needed?
- Which analytical techniques may be appropriate?
- Is an established method sufficient?
- Does a method need to be developed or adapted?
- Should the project be completed in stages?
- Will the results support internal decisions, product development, quality activities, or regulatory use?
CMDC Labs can help organizations work through these questions and translate a broad scientific or technical challenge into an actionable project.
Scientific Project Planning
Build the Scientific Approach Before Starting the Work
Complex scientific projects may involve multiple questions, samples, analytical techniques,
development stages, and stakeholders.
Beginning laboratory work without a clear scientific objective can produce data without
necessarily producing an answer.
CMDC Labs can support scientific project planning involving:
- Scientific objective definition
- Project scope development
- Testing sequence planning
- Sample strategy
- Control and comparison strategy
- Analytical approach selection
- Experimental planning
- Scientific risk identification
- Project-stage development
- Data requirements
- Follow-up investigation planning
- Coordination between related scientific activities
The objective is to establish a practical scientific framework before significant laboratory
resources are committed.
Testing Strategy Development
Determine What the Testing Program Actually Needs to
Accomplish
A testing strategy should begin with the purpose of the testing—not simply a list of available
laboratory methods.
CMDC Labs can help organizations evaluate:
- What needs to be measured
- Why the measurement matters
- Which samples should be tested
- Which comparison samples or controls may be useful
- Which laboratory disciplines may be relevant
- Whether multiple techniques are required
- Which work should occur first
- Whether one stage should determine the next
- How results will ultimately be used
Testing-strategy development can be particularly valuable for product development, scientific
troubleshooting, research, quality investigations, and technically complex projects.
Study Design & Experimental Design
Build Studies Around the Question You Need to Answer
Scientific studies require more than selecting an analytical method.
The structure of the study itself can determine whether the resulting information is useful.
Depending on the project, CMDC Labs can support consideration of:
- Study objectives
- Experimental variables
- Sample selection
- Comparison groups
- Controls
- Testing conditions
- Measurement approaches
- Study sequence
- Data requirements
- Potential sources of variability
- Follow-up experiments
This can support research projects, product development, feasibility studies, failure
investigations, comparative studies, and other customized scientific work.
Analytical Strategy & Method Selection
Match the Scientific Question With the Appropriate
Analytical Approach
Different analytical technologies provide different types of information.
Depending on the project, CMDC Labs may draw from capabilities involving:
- HPLC
- LC-MS/MS
- GC / GC-MS
- ICP-MS
- FTIR
- Raman Spectroscopy
- SEM
- XPS
- PCR
- Flow Cytometry
- Cell Culture
- Cell-Based Assays
- Microbiological Methods
- Surface Characterization
- Materials Characterization
- Microscopy
The objective is not to select an instrument because it is available.
It is to determine which analytical approach can provide information relevant to the scientific
question.
Method Development & Method Selection
Generate Scientific Information for Quality, Development
& Appropriate Regulatory Objectives
Standard methods are appropriate for many laboratory projects.
Other projects involve unusual materials, products, formulations, matrices, research objectives,
or analytical questions for which an established approach may not be sufficient.
CMDC Labs can support appropriate projects involving:
- Method selection
- Method adaptation
- Custom method development
- Sample preparation strategy
- Analytical feasibility
- Detection strategy
- Method optimization
- Method performance evaluation
Where a method will ultimately require formal validation, the intended use of the method should
be considered during development.
Method Validation
Scientific Problems Look Different in Every Industry
When a method will be used for a defined analytical purpose, organizations may need evidence
that it performs appropriately for that intended use.
CMDC Labs can support appropriate method-validation projects based on the method, scientific
objective, intended application, and applicable project requirements.
Where results are intended for regulatory submission or monitoring, laboratory qualifications
and other applicable requirements should be reviewed before work begins.
Scientific Troubleshooting Consultation
When You Know Something Is Wrong but Don't Know Where to Start
A product failure, contamination event, unexpected laboratory result, manufacturing change,
material problem, or quality issue may not immediately reveal which type of testing is needed.
The problem could involve:
- Chemistry
- Microbiology
- Materials
- Manufacturing
- Formulation
- Packaging
- Environment
- Storage
- Raw materials
- Multiple interacting factors
Scientific consultation can help organize the available evidence, identify potential investigation
pathways, and determine what information may be useful next.
Where appropriate, consultation can transition directly into a multidisciplinary scientific
investigation.
Product Development Consulting
Scientific Guidance Throughout the Development Process
Product-development teams encounter scientific decisions from early feasibility through commercialization.
These may involve:
- Product concepts
- Prototype evaluation
- Material selection
- Ingredient selection
- Formulations
- Product characterization
- Analytical methods
- Stability
- Shelf life
- Product optimization
- Verification
- Validation
- Manufacturing transition
- Commercialization
CMDC Labs can help determine which scientific questions should be addressed at different
stages and which laboratory approaches may provide useful information.
Research Consulting
Research projects frequently involve questions that do not fit into predefined testing packages.
CMDC Labs can support universities, startups, manufacturers, technology developers, research
organizations, and internal R&D teams with scientific planning for appropriate projects involving:
- Applied research
- Proof-of-concept studies
- Pilot studies
- Technology evaluation
- Experimental research
- Method development
- Product innovation
- Scientific collaboration
- Laboratory research programs
Consultation can help translate a research objective into a practical experimental and laboratory
approach.
Scientific Data Interpretation
Laboratory Data Should Help Answer a Question
Generating laboratory results is only one part of the scientific process.
Organizations may also need to understand:
- What the results indicate
- Which differences may be meaningful
- Whether findings support the original hypothesis
- How multiple datasets relate to one another
- Whether an unexpected result warrants additional investigation
- Which questions remain unanswered
- Whether further testing may be useful
CMDC Labs can provide scientific interpretation for appropriate projects based on the available
data and project context.
Scientific Review & Technical Report Review
Existing scientific work may require technical review before an organization determines its next
step.
Depending on the project, CMDC Labs can evaluate available:
- Laboratory results
- Scientific reports
- Testing programs
- Experimental information
- Analytical methods
- Technical documentation
- Previous investigations
- Product-development data
The purpose of the review may be to identify scientific gaps, clarify findings, determine whether
additional work may be appropriate, or support planning of the next stage.
Where appropriate, scientific review can transition into testing, investigation, research, or
consulting work.
Scientific Project Management
Coordinate Complex Scientific Programs Across Multiple
Activities
Some projects extend beyond a single laboratory analysis.
They may involve multiple analytical methods, development stages, comparison studies,
investigations, technical reviews, or related scientific activities.
For appropriate projects, CMDC Labs can help structure and coordinate the scientific
components of a broader program.
This may include:
- Project scope coordination
- Scientific work sequencing
- Testing-stage coordination
- Data review between project stages
- Identification of follow-up questions
- Coordination of multidisciplinary laboratory work
- Scientific communication throughout the project
- Understand degradation
- Characterize manufacturing changes
- Evaluate new ingredients
- Investigate customer feedback
Laboratory Program Development
Organizations with recurring or complex laboratory requirements may benefit from developing a
more structured scientific testing program rather than approaching every analysis
independently.
CMDC Labs can help evaluate laboratory programs involving:
- Recurring testing needs
- Product-development programs
- Quality-monitoring programs
- Research programs
- Manufacturing support
- Environmental monitoring
- Product characterization
- Analytical strategies
- Scientific investigation pathways
- Evaluate new ingredients
- Investigate customer feedback
The objective is to create a laboratory approach aligned with the organization’s scientific and
operational needs.
Risk Assessment & Scientific Decision Support
Scientific decisions frequently involve uncertainty.
Organizations may need to evaluate available evidence before determining whether additional
investigation, testing, development, or corrective action is appropriate.
Depending on the project, scientific consulting may help assess:
- Available scientific evidence
- Known and unknown variables
- Potential failure mechanisms
- Data gaps
- Testing limitations
- Product or process differences
- Potential areas requiring additional investigation
- Storage
- Product consistency
- Microbiological conditions
CMDC Labs can provide scientific information and technical perspective to support decision-
making.
Final product, regulatory, quality, safety, or business decisions remain the responsibility of the
organization.
Quality Investigation & CAPA Scientific Support
Quality problems may require scientific investigation beyond determining whether a specification
was met.
Organizations may need scientific support involving:
- Nonconforming products
- Unexpected results
- Batch differences
- Customer complaints
- Contamination
- Manufacturing changes
- Material changes
- Product failures
- Deviations
- Root-cause investigation
- CAPA-related scientific questions
CMDC Labs can provide appropriate laboratory data and scientific support that may contribute
to an organization’s broader quality or CAPA process.
Responsibility for CAPA decisions and quality-system conclusions remains with the organization.
Regulatory-Related Scientific Planning
Projects involving regulatory submissions or regulatory monitoring may have specific
requirements related to methods, laboratory qualifications, documentation, validation, and
intended use of the resulting data.
CMDC Labs can help evaluate the scientific and laboratory components of appropriate
regulatory-related projects.
During project qualification, tell us:
Will these laboratory results be submitted to or used for monitoring by a regulatory
body?
If yes, CMDC Labs can evaluate the intended use and determine whether the proposed work
falls within the appropriate laboratory capabilities, methods, accreditation scope, certifications,
and other applicable requirements.
Clients do not need to determine those laboratory requirements before contacting us.
Scientific Documentation & Communication
Scientific findings often need to be communicated to people beyond the laboratory.
Depending on the project, this may involve:
- Scientific reports
- Technical reports
- Research documentation
- Testing summaries
- Scientific publications
- Technical specifications
- Development documentation
- Data interpretation
- Regulatory-related technical documentation
CMDC Labs’s existing Scientific Writing capabilities can complement consulting, testing,
research, and product-development projects where scientific information needs to be translated
into clear technical documentation.
Scientific Consulting Across the Project Lifecycle
Scientific guidance may be useful at virtually any stage.
Research & Discovery
Scientific planning, experimental design, proof-of-concept, feasibility, and technology evaluation.
Product Development
Testing strategy, materials, ingredients, formulations, prototypes, characterization, analytical
methods, and optimization.
Verification & Validation
Testing strategy, methods, scientific planning, data generation, and interpretation.
Manufacturing
Process investigation, product consistency, contamination, material changes, troubleshooting,
and quality support.
Commercialization
Validation-related support, laboratory programs, technical documentation, scientific review, and
product support.
Existing & Post-Market Products
Customer complaints, product failures, manufacturing changes, quality investigations, scientific
troubleshooting, and product improvement.
Scientific Consulting Across Industries
CMDC Labs' multidisciplinary capabilities allow scientific consulting to support appropriate projects across multiple industries.
Medical Device & Biotechnology
Product development, materials, surfaces, testing strategy, characterization, biological
response, troubleshooting, verification/validation support, and scientific planning.
Food & Beverage
Product development, ingredients, shelf life, microbiology, contamination, manufacturing
problems, product quality, and formulation questions.
Pharmaceutical & Life Sciences
Analytical strategy, microbiology, methods, stability, development, research, quality
investigations, and scientific planning.
Agriculture, Dairy & Livestock
Water, soil, feed, ingredients, product quality, contamination, agricultural products,
manufacturing questions, and scientific investigation.
Environmental & Water
Water quality, contamination, analytical strategy, environmental investigations, industrial water,
monitoring programs, and scientific planning.
Research & Innovation
Experimental design, proof-of-concept, analytical strategy, methods, technology evaluation,
scientific collaboration, and research planning.
From Scientific Question to Laboratory Work
One advantage of working with a multidisciplinary scientific laboratory is the ability to connect
consultation with practical laboratory capabilities.
A project may progress through:
Scientific Question
↓
Scientific Consultation
↓
Testing / Study / Investigation Strategy
↓
Laboratory Analysis
↓
Scientific Data Interpretation
↓
Additional Investigation, Development, or Decision
The scientific approach can therefore evolve as new information becomes available.
How a Scientific Consulting Project Begins
Step 1 — Tell Us About the Challenge
Describe the product, problem, research objective, development project, quality concern, or scientific question.
Step 2 — Share What You Already Know
Useful information may include:
- Existing laboratory results
- Product information
- Specifications
- Previous investigations
- Research data
- Photographs
- Technical documents
- Sample information
- Manufacturing history
- Known changes
Step 3 — Define the Scientific Objective
What are you trying to understand?
What decision should the resulting information help support?
Step 4 — Determine the Appropriate Scientific Path
The next step may involve:
- Scientific consultation
- Laboratory testing
- Study design
- Experimental work
- Scientific troubleshooting
- Product characterization
- Product development
- Method development
- Research support
- Data interpretation
- A customized scientific investigation
Step 5 — Move Into the Appropriate Work
Once the scientific objective and scope are established, the project can transition into the appropriate consulting, laboratory, research, development, or investigation pathway.
Already Know Which Testing You Need?
If your scientific question and testing requirements are already clearly defined, you do not necessarily need scientific consulting.
You can move directly into the appropriate laboratory-testing pathway.
Not Sure What Comes Next?
You do not need to determine the laboratory method before contacting CMDC Labs.
Start by telling us:
What are you trying to understand?
What information do you already have?
What decision are you trying to make?
Where are you getting stuck?
CMDC Labs can review the situation and determine whether our scientific and laboratory
capabilities are appropriate for the project.
Start With the Question. Build the Scientific Path From There.
Good scientific work begins before an instrument starts generating data.
It begins by understanding the question.
CMDC Labs combines multidisciplinary laboratory capabilities with scientific consulting, product-development experience, research support, troubleshooting, analytical expertise, and technical investigation to help organizations determine what information they need and how that information may be generated.
Whether the next step is a consultation, laboratory test, customized investigation, research program, product-development project, or broader scientific collaboration, CMDC Labs can help establish an appropriate path forward.
