Regulatory Compliance Associates (RCA) has helped clients from around the world develop stage-ready 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 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

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

 

Monkeypox – Virus Efficacy Testing

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

 

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

Regulatory Compliance Associates^® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:

 

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

 

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.

 

• Founded in 2000
• Headquartered in Wisconsin (USA)
  • Regional offices in Florida, Colorado and Europe
• Expertise backed by over 500 industry subject matter experts
• Acquired by Sotera Health in 2021

 

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.