Lab Testing

Regulatory Compliance Associates® (RCA) has helped clients from around the world develop stage-ready lab testing based on each product’s regulatory pathway.  Our comprehensive lab testing services include supporting pre-formulation, process development for formulation, and formulation manufacturing. The following includes a high level overview of lab testing solutions, solubility and dissolution testing, stability testing, solid form testing we conduct for new product development clients.

 

Lab Testing

 

  • Biocompatibility
  • Toxicology
  • Extractables & Leachables
  • Sterility Assurance
  • Validation

 

Biologics Testing

 

  • Contamination Testing
  • Bioactivity Testing
  • Potency Testing

 

Stability Testing

 

  • Lot Testing
  • Viral Clearance
  • Protein Testing
  • Cell Line Testing
  • Product Release

 

ISO 17025 Testing

 

  • Aerobic Plate Count
  • Yeast Plate Count
  • Mold Plate Count
  • Appearance testing
  • Color testing
  • Odor testing
  • pH testing
  • Heavy Metals testing

 

Skincare Testing

 

  • Cosmetic Testing
    • Anti-aging
      • Fine Lines and Wrinkles
      • Evens Skin Tone
      • Moisturizes/Hydrates
      • Exfoliates
      • Promotes Healing
      • Barrier Repair
      • Restores Damaged Skin
    • Anti-Inflammatory
      • Reduces Erythema
      • Reduces Pore Size
    • Non-Irritating
      • Wound Healing
      • Hypoallergenic
      • Dermatologist Testing
      • Ophthalmologist Tested
    • Acne
      • Spot reduction
      • Lesion reduction
      • Skin tone comparison
      • Image analysis

 

Validation Lab Testing

 

Facility & Process Validation lab testing

  • Cleanroom Validation
    • Installation Qualification  
    • Operational Qualification 
    • Performance Qualification
  • Water System Validation
    • Sampling
    • Microbiological Testing
    • Alert and Action Limits
  • Process Validation
    •  RMM
    • Surfaces
  • Sterilization Validation
    • ISO 11135 (ethylene oxide)
    • ISO 11137 (radiation sterilization)
  • Re-Use Validation
    • Device reprocessing
    • Cleaning
    • Disinfection
    • Sterilization
  • Packaging Validation
    • ISO 11607-1:2019
      • Requirements for materials
      • Sterile barrier systems
      • Packaging systems
    • ISO 11607-2:2019 
      • Validation requirements
      • Forming
      • Sealing

Biological evaluation lab testing

  • Biological Evaluation Plan
  • In Vitro Biocompatibility
    • Cytotoxicity testing
    • Hemocompatibility testing
    • Genotoxicity testing
  • In Vivo Biocompatibility
    • Implantation testing
    • Irritation testing
    • Thrombogenicity testing
    • Sensitization testing
    • Systemic Toxicity testing
    • Genotoxicity
  • Chemical Characterization (E&L)
    • Gas Chromatography/Mass Spectrometry
    • Liquid Chromatography/Mass Spectrometry
    • LC Chromatogram
    • Inductively Coupled Plasma
  • Toxicology Assessment
    • Hazard identification
    • Data evaluation
    • Exposure assessment
    • Dose-response analysis
    • Risk characterization

 

 

Sterilization Lab Testing

 

Radiation validation lab testing

  • Product Sterility
    • Product shelf life
    • Stability and/or package integrity
  • Verification Dosing
    • Maximum Dose
    • Dose Mapping
  • Bioburden
    • Test Method Validation
  • Bacteriostasis/Fungistasis
    • Microbial contamination
    • Method suitability 
    • Method validation
  • BET/Particulates

EO validation lab testing

  • BI Sterility
    • Steam Sterilization (Autoclaves)
    • Vaporized Hydrogen Peroxide Sterilization
  • Product Sterility
  • Bioburden
  • EO Residuals
  • BET/Particulates
  • PCD’s

Re-Use validation lab testing

  • Cleaning
  • Disinfection
  • Sterilization
  • Clinical Monitoring
  • Simulated Use
  • Lifecycle Testing

Packaging validation lab testing

  • Aging (real-time)
  • Aging (accelerated)
  • Strength and Integrity
  • Distribution Studies
  • Thermal & RH Cycling
  • Stability Testing

 

 Sterility Lab Testing

 

  • QDA (Radiation)
    • Product Sterility
    • Verification Dosing
    • Bioburden
    • BET/Particles
  • ED Lot Release
    • BI Sterility
    • EO Residuals
    • BET/Particulates
    • PCD’s
  • Other Sterility Assurance
    • Bioburden
    • Organism ID’s
    • Cytotoxicity

 

Consumer Product Lab Testing

 

  • Personal and Professional products
    • Antiperspirant testing
    • Moisturization testing
    • Hydration testing
    • Dermatologically tested claims

 

Disinfectant Claim (Coronavirus)

  • Testing standards for SARS-COV-2:
    • ASTM – E1053
    • ASTM – E1052
    • EN – 14476
    • ISO – 18184
    • ISO – 21702

 

Virus Efficacy Claim (Monkeypox)

  • Testing standards for Monkeypox:
    • ASTM – E1053
    • ASTM – E1052
    • EN – 14476
    • ISO – 18184
    • ISO – 21702

 

Lab Compliance Consulting

 

  • ALCOA+ data integrity programs
  • Analytical instrument qualification (AIQ)
  • Chromatography data system (CDS)
  • Custom validation services
  • Computer system validation (CSV)
  • Custom procedure writing
  • Cyber-security software protection
  • Equipment qualification plans (EQPs)
  • Equipment qualification reports (EQRs) 
  • Instrument and software qualifications (IQOQ, OQ ,and RQ)
  • IVD Test Implementation 
  • Qualification electronic traceability

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

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