Quality & Regulatory Support
Scientific & Laboratory Support for Quality, Validation, Compliance, and Regulatory-Related Projects
Quality and regulatory requirements often depend on one fundamental element:
Reliable scientific evidence.
Organizations may need laboratory data to verify product quality, investigate failures, validate
methods or processes, evaluate contamination, support product development, respond to
quality concerns, or address requirements associated with regulated products and
environments.
CMDC Labs provides multidisciplinary scientific and laboratory support for appropriate quality,
validation, verification, compliance, and regulatory-related projects.
Our team works with manufacturers, product developers, researchers, quality teams, and other
organizations to understand the scientific objective, intended use of the resulting data, and
applicable laboratory requirements before work begins.
CMDC Labs is
accredited under
Start With the Intended Use of the Data
CMDC Labs can help determine which scientific capabilities and laboratory approaches may be appropriate for the research objective.
- Generate preliminary scientific data
- Evaluate feasibility
- Compare technologies
- Characterize a material or product
- Develop an experimental approach
- Evaluate prototypes
- Develop or adapt an analytical method
- Investigate biological or microbiological behavior
- Understand chemical composition
- Study surfaces or materials
- Generate proof-of-concept information
- Evaluate unexpected findings
- Develop a larger research program
may involve different methods, documentation, laboratory qualifications, accreditation
requirements, or project controls.
For this reason, one of the most important questions CMDC Labs asks during project
qualification is:
Will these laboratory results be submitted to or used for monitoring by a regulatory
body?
If the answer is Yes or Not Sure, our team can evaluate the intended use of the data and
determine whether the requested work falls within the appropriate CMDC Labs capabilities,
methods, accreditation scope, certifications, and other applicable requirements.
Clients do not need to determine these laboratory requirements themselves before contacting
us.
Quality Testing Support
Generate Scientific Data to Support Product and Process
Quality
Quality programs may require laboratory testing throughout a product or process lifecycle.
Depending on the industry and project, CMDC Labs capabilities may support evaluation of:
- Product quality
- Raw materials
- Ingredients
- Microbiological quality
- Chemical composition
- Contaminants
- Trace metals
- Materials
- Surfaces
- Water
- Environmental conditions
- Product consistency
- Stability
- Shelf life
- Biological response
- Manufacturing changes
Testing can support routine quality activities as well as investigation of unexpected results or
changes.
Product Verification Support
Generate Data Against Defined Product Requirements
Organizations may need laboratory evidence to evaluate whether a product, material,
component, formulation, or other defined characteristic meets established requirements.
Depending on the project, verification-related laboratory work may involve:
- Analytical testing
- Chemical analysis
- Materials characterization
- Microbiological testing
- Product characterization
- Biological-response testing
- Comparative testing
- Stability-related testing
- Customized laboratory studies
CMDC Labs can evaluate appropriate verification projects based on the defined requirements
and intended use of the resulting data.
Validation Support
Scientific Testing for Defined Validation Objectives
Validation programs may require evidence that a method, process, product, system, or
procedure performs appropriately under defined conditions.
Depending on the project and CMDC Labs’ applicable capabilities, laboratory support may
contribute to:
- Method validation
- Product validation
- Process-related studies
- Sterility validation
- Cleaning-related investigation or testing
- Analytical validation activities
- Microbiological validation activities
- Customized validation studies
Validation requirements vary significantly by application.
The project objective, protocol, applicable requirements, and intended use of the resulting data
should therefore be reviewed before testing begins.
Method Validation
Analytical and microbiological methods may require validation or other performance evaluation
depending on their intended application.
CMDC Labs can support appropriate method-validation projects involving consideration of
relevant performance characteristics based on the method and intended use.
- Established methods
- Adapted methods
- Newly developed methods
- Product-specific methods
- Matrix-specific analytical approaches
- Customized laboratory procedures
- Assess preliminary trends
- Identify potential technical challenges
- Refine the scope of subsequent research
Where a method will support regulatory or formal quality activities, applicable requirements should be identified during project qualification.
Method Development Before Validation
A method cannot always move directly into validation.
New products, unusual materials, complex matrices, emerging technologies, specialized
formulations, or unique analytical objectives may first require method development or
adaptation.
CMDC Labs can support appropriate method-development work involving:
- Analytical approach selection
- Sample preparation
- Detection strategy
- Method adaptation
- Analytical feasibility
- Method optimization
- Method performance evaluation
Once an appropriate analytical approach has been established, the project may progress
toward validation if required.
Quality Investigation Support
When a Quality Problem Requires Scientific Investigation
A quality issue does not always reveal its cause.
Organizations may encounter:
- Failed specifications
- Unexpected laboratory results
- Batch-to-batch differences
- Product degradation
- Contamination
- Manufacturing changes
- Raw-material differences
- Customer complaints
- Packaging concerns
- Product-performance changes
- Unknown materials or residues
- Microbiological problems
CMDC Labs can provide scientific and laboratory support to help characterize the problem and
generate information that may contribute to a broader quality investigation.
Root Cause Analysis Support
Identifying that a failure occurred is different from understanding why it occurred.
Scientific root-cause work may require multiple sources of evidence.
Depending on the problem, CMDC Labs may support investigations involving:
- Failed vs. acceptable sample comparison
- Chemical analysis
- Microbiological analysis
- Materials characterization
- Contaminant identification
- Manufacturing-process investigation
- Product characterization
- Environmental investigation
- Failure reproduction
- Additional targeted testing
Laboratory data may help evaluate hypotheses and narrow potential causes.
Final root-cause conclusions remain dependent on the totality of information available to the
organization.
CAPA Scientific Support
Laboratory Evidence for Corrective and Preventive Action Investigations
Corrective and Preventive Action programs may require scientific information when
organizations investigate failures, nonconformances, contamination, unexpected results,
manufacturing problems, or product-quality concerns.
CMDC Labs can provide appropriate scientific and laboratory support that may contribute to
CAPA activities.
Support may include:
- Failure characterization
- Comparative testing
- Contaminant identification
- Material characterization
- Chemical analysis
- Microbiological analysis
- Root-cause investigation support
- Failure reproduction
- Scientific data generation
- Data interpretation
CMDC Labs provides laboratory data and scientific support.
Nonconformance & Unexpected Result Investigation
An unexpected result can have many possible explanations.
It may reflect:
- A genuine product difference
- Raw-material variation
- Manufacturing variation
- Contamination
- Sample-related factors
- Material changes
- Product degradation
- Environmental conditions
- Analytical variables
- Another unidentified cause
Where appropriate, scientific investigation can help characterize the unexpected finding and
determine which additional information may be useful.
CMDC Labs can support laboratory investigation while the organization’s quality team manages
the broader quality-system process.
Customer Complaint Investigation
Customer complaints can reveal quality concerns that may be difficult to reproduce internally.
Examples may involve:
- Product appearance
- Foreign material
- Residue
- Odor
- Discoloration
- Product degradation
- Contamination
- Product performance
- Packaging
- Product inconsistency
- Comparative studies
Where samples and appropriate comparison materials are available, laboratory analysis may
help characterize the reported problem.
Useful comparisons can include:
- Complaint vs. retained sample
- Failed vs. acceptable product
- Current vs. historical batch
- Different production lots
- Different suppliers
- Exposed vs. unexposed samples
Manufacturing Quality Investigation
Understand Scientific Differences When Manufacturing
Changes
Manufacturing changes can introduce differences that are not immediately visible.
Quality concerns may emerge following changes involving:
- Raw materials
- Suppliers
- Equipment
- Process conditions
- Production scale
- Cleaning procedures
- Packaging
- Storage
- Environmental conditions
- Manufacturing location
CMDC Labs can support comparative and investigative laboratory work to help determine
whether measurable scientific differences exist between products, materials, or processes.
Contamination Investigation
Contamination can affect product quality, manufacturing, laboratory environments, water
systems, raw materials, ingredients, packaging, and other components of a quality program.
Depending on the suspected contaminant, investigation may involve:
- Microbiology
- Chemical analysis
- Materials characterization
- Particle analysis
- Metals analysis
- Environmental testing
- Water testing
- Unknown-material identification
- Comparative analysis
The appropriate approach depends on what is known about the contamination and what the
organization needs to determine.
Sterility & Bioburden Support
Microbiological quality is particularly important for products and processes where microbial
contamination may affect safety, quality, performance, or compliance.
Depending on the project, CMDC Labs capabilities may support:
- Sterility testing
- Sterility validation
- Bioburden testing
- Microbial enumeration
- Microbial identification
- Environmental monitoring
- Contamination investigation
- Method-related work
- Scientific troubleshooting
Where work is intended for a specific regulatory or quality application, project requirements
should be qualified before testing begins.
Stability & Shelf-Life Support
Product quality can change over time.
Stability and shelf-life programs may help organizations evaluate changes involving:
- Chemical composition
- Product degradation
- Microbiological quality
- Ingredients
- Materials
- Packaging
- Environmental exposure
- Storage temperature
- Humidity
- Product performance
- Other defined quality characteristics
CMDC Labs can support appropriate stability and shelf-life studies according to the product,
scientific objective, and intended use of the resulting data.
Raw Material & Supplier Quality Support
Finished-product quality can depend heavily on incoming materials and suppliers.
Organizations may need to evaluate:
- Raw-material consistency
- Ingredient quality
- Chemical composition
- Microbiological quality
- Contaminants
- Trace metals
- Material identity
- Supplier differences
- Lot-to-lot variation
- Changes associated with a new supplier
Comparative laboratory testing may help identify measurable differences between materials or
suppliers.
Environmental & Water Quality Support
Water and environmental conditions can influence manufacturing, products, facilities, research,
food production, agriculture, healthcare environments, and industrial processes.
CMDC Labs’ capabilities may support appropriate projects involving:
- Drinking water
- Process water
- Wastewater
- Groundwater
- Environmental contamination
- Microbiological water quality
- PFAS
- Heavy metals
- Chemical contaminants
- Industrial water
- Environmental monitoring
Where testing is performed for regulatory monitoring or compliance purposes, applicable
program and laboratory requirements must be evaluated during project qualification.
Regulatory-Related Laboratory Support
Match the Laboratory Work to the Intended Regulatory
Purpose
Regulatory-related projects can involve specific requirements concerning:
- Laboratory qualifications
- Accreditation
- Certifications
- Methods
- Validation
- Documentation
- Reporting
- Sampling
- Quality controls
- Program-specific requirements
CMDC Labs evaluates appropriate projects based on the intended use of the resulting data.
This qualification step is particularly important because having the technical capability to
perform an analysis does not automatically mean that every regulatory application of that
analysis falls within the same laboratory scope.
Before work begins, tell us:
Which product, program, agency, or requirement is associated with the project?
How will the resulting data be used?
CMDC Labs can then evaluate whether the project can be appropriately supported.
Regulatory Testing Strategy
Organizations may know that laboratory data will be required but may not yet know how the
testing program should be structured.
CMDC Labs can provide scientific consultation for appropriate projects involving:
- Testing strategy
- Method selection
- Analytical approach
- Sample strategy
- Validation considerations
- Scientific project planning
- Data requirements
- Laboratory qualification considerations
- Identification of scientific gaps
The applicable regulatory requirements remain dependent on the specific product, program,
jurisdiction, and intended use.
Scientific Documentation Support
Laboratory and scientific work may need to be communicated through clear technical
documentation.
Depending on the project, CMDC Labs’ Scientific Writing capabilities may support:
- Scientific reports
- Technical reports
- Testing summaries
- Research documentation
- Data interpretation
- Technical specifications
- Product-development documentation
- Scientific publications
- Regulatory-related technical documentation
Documentation requirements should be defined according to the purpose of the project.
Quality & Regulatory Support Across Industries
Medical Device & Biotechnology
Appropriate support may involve product characterization, materials, microbiology, sterility,
bioburden, biological response, verification, validation, failure investigation, analytical testing,
and scientific documentation.
Food & Beverage
Support may involve microbiology, pathogens, AOAC-related testing, product quality, shelf life,
ingredients, contamination, manufacturing investigations, and analytical testing.
Pharmaceutical & Life Sciences
Appropriate projects may involve microbiology, analytical chemistry, stability, methods,
contamination investigation, quality support, and scientific documentation.
Agriculture, Dairy & Livestock
Projects may involve water, feed, ingredients, contaminants, microbiology, product quality,
environmental conditions, and agricultural products.
Water & Environmental
Projects may involve drinking water, wastewater, PFAS, contaminants, environmental
monitoring, industrial water, and other applicable quality or compliance requirements.
Industrial & Consumer Products
Support may involve materials, chemicals, contaminants, manufacturing changes, product
consistency, failure investigation, and quality testing.
CMDC Labs Qualifications
The requirements applicable to a laboratory project depend on the testing being performed and
the intended use of the results.
CMDC Labs maintains laboratory qualifications applicable to defined areas of its work, including
ISO/IEC 17025:2017 accreditation through Perry Johnson Laboratory Accreditation
(PJLA).
The applicable accreditation scope and other project-specific requirements should be confirmed
during project qualification rather than assumed based solely on the general laboratory
capability.
Quality & Regulatory Support Across the Product Lifecycle
Quality and regulatory considerations can arise throughout a product’s lifecycle.
Research & Development
Establish scientific understanding and generate early data.
Product Development
Characterize products, materials, formulations, methods, stability, and performance.
Verification
Generate scientific evidence against defined requirements.
Validation
Support appropriate validation activities based on defined objectives.
Manufacturing
Monitor quality and investigate unexpected changes.
Commercialization
Support appropriate testing, documentation, and quality programs.
Existing / Post-Market Products
Investigate complaints, failures, contamination, product changes, and other quality concerns.
How a Quality or Regulatory Project Begins
Step 1 — Tell Us What You Need to Accomplish
Describe the product, sample, quality concern, validation activity, regulatory-related objective, or
testing requirement.
Step 2 — Tell Us How the Data Will Be Used
This is critical.
Will the results support:
- Internal research?
- Product development?
- Quality investigation?
- Routine monitoring?
- Verification?
- Validation?
- Regulatory submission?
- Regulatory monitoring?
- Another defined purpose?
Step 3 — Project Qualification
CMDC Labs evaluates:
- Scientific requirements
- Laboratory capabilities
- Methods
- Intended use
- Applicable accreditation scope
- Applicable certifications
- Documentation requirements
- project-specific considerations
Step 4 — Define the Laboratory Approach
The project may involve:
- Routine testing
- Customized testing
- Validation work
- Scientific investigation
- Method development
- Comparative analysis
- Product characterization
- Scientific consultation
- Multiple laboratory disciplines
Step 5 — Perform the Appropriate Scientific Work
Once the scope and requirements are established, the agreed laboratory work can proceed.
Already Know the Required Test or Method?
If your organization has already established the testing requirements, method, samples,
specifications, and intended use, CMDC Labs can evaluate the defined project directly.
Not Sure How to Structure the Research?
You do not need to determine every laboratory or qualification requirement yourself.
Tell us:
What are you testing?
Why are you testing it?
How will the results be used?
Is a regulatory body involved?
CMDC Labs can evaluate the project and determine whether our scientific capabilities and applicable laboratory qualifications are appropriate.
Build Quality Decisions on Reliable Scientific Information
Quality systems, validation programs, regulatory activities, and product decisions depend on scientific information that is appropriate for its intended purpose.
CMDC Labs combines multidisciplinary laboratory testing with scientific investigation, analytical expertise, product-development support, research capabilities, and scientific consulting to help organizations generate and understand that information.
From routine quality testing to complex failure investigations, method development, validation support, product verification, CAPA-related scientific work, and regulatory-related laboratory projects, the process begins by understanding what information is needed and how it will be used.
