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

 

About Regulatory Compliance Associates

 

Regulatory Compliance Associates (RCA) provides lab testing consulting to the following industries for resolution of life science challenges:

 

• Life Sciences
• 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, Health Canada, MHRA and globally-regulated companies.

 

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

 

• Founded in 2000
• Headquartered in Wisconsin (USA)
• Expertise backed by over 500 industry subject matter experts
• Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health^®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics^®, Nordion^® and Nelson Labs^®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,000 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

 

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.