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.
Regulatory Compliance Associates® Lab Testing
- Biocompatibility
- Toxicology
- Extractables & Leachables
- Sterility Assurance
- Validation
Cosmetic Testing & Skin Care Lab 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
- Anti-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
- Water Loss (Barrier Properties)
- In-Use Studies
- Moisturization/Hydration
Regulatory Compliance Associates® Validation Lab Testing
Facility & Process Validation lab testing
|
Biological evaluation lab testing
|
Regulatory Compliance Associates® Sterilization Lab Testing
Radiation validation lab testing
|
EO validation lab testing
|
Re-Use validation lab testing
|
Packaging validation lab testing
|
Regulatory Compliance Associates® 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
Disinfectant Claim Lab Testing (Coronavirus)
- Testing standards for SARS-COV-2:
- ASTM – E1053
- ASTM – E1052
- EN – 14476
- ISO – 18184
- ISO – 21702
Virus Efficacy Claim Lab Testing (Monkeypox)
- Testing standards for Monkeypox:
- ASTM – E1053
- ASTM – E1052
- EN – 14476
- ISO – 18184
- ISO – 21702
Lab Compliance Consulting
|
|
About RCA
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 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.