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

 

 

RCA Pharmaceutical & Medical Device Testing

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

 

Cosmetic Testing & Skin Care Testing

  • Personal and Professional products
    • Moisturization/Hydration
      • Moisturization Testing
      • Dermatologically tested claims
    • Anti-aging
      • Claim Testing
        • Fine Lines and Wrinkles
        • Evens Skin Tone
        • Moisturizes/Hydrates
        • Exfoliates
        • Promotes Healing
        • Barrier Repair
        • Restores Damaged Skin
        • Antit-Inflammatory
        • Reduces Erythema
        • Reduces Pore Size
        • Non-Irritating
        • Wound Healing
        • Hypoallergenic
        • Dermatologist Testing
        • Ophthalmologist Tested
        • Acne
        • Onychomycosis
        • Antiperspirant
        • Plaque Reduction (PGRM)
        • Whitening
    • Skin Tone
    • Acne Spot Reduction
    • Lesion Reduction
    • Image Analysis
    • Transepidermal Water Loss (Barrier Properties)
    • In-Use Studies

RCA Validation Testing

Facility & Process validation

  • 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 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 validation testing services

Radiation validation 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 testing

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

Re-Use validation testing

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

Packaging validation testing

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

 

Sterility assurance 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

 

Coronavirus – Disinfectant Claim Testing

 

Monkeypox – Virus Efficacy Testing

 

Lab compliance services

  • 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

 

About RCA

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

 

To begin the RCA® 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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