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
- Claim Testing
- Skin Tone
- Acne Spot Reduction
- Lesion Reduction
- Image Analysis
- Transepidermal Water Loss (Barrier Properties)
- In-Use Studies
- Moisturization/Hydration
RCA Validation Testing
Facility & Process validation
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Biological evaluation testing
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Sterilization validation testing services
Radiation validation testing
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EO validation testing
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Re-Use validation testing
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Packaging validation testing
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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
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About RCA
Regulatory 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.
- 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