Cosmetic Product Safety Report & Assessment

Cosmetic Product Safety Assessment (CPSR)

Bringing professional support at your doorstep!

Our Cosmetic Product Safety Assessment (CPSR) service ensures that you have no compliance gaps when it comes to safety regulations. We understand that the cosmetic industry is dynamic and competitive, and ensuring the safety of your products is paramount to success in the market.

Our CPSR service is designed to help you navigate the complex landscape of regulatory compliance, ensuring your products meet the highest safety standards while adhering to all relevant regulations of the desired market.

50+

Years Of
Collective Experience

250 +

Successful projects

200 +

Experience Team

100 +

Global Clients

Why Cosmetic Product Safety Assessment (CPSR)?

Cosmetic products must meet specific safety requirements to protect consumers and maintain market credibility. Regulatory agencies worldwide, including the FDA, Healthcare Canada, European Medicines Agency (EMA), and others have established strict guidelines for assessing the safety of cosmetic products. Failure to comply can result in costly recalls, legal consequences, and damage to your brand's reputation.

Let’s talk how we can help!

Key Aspects of Cosmetic Product Safety Assessment

Our Expertise

Packaging and Labeling Compliance

Our team ensures that your product packaging and labeling are in full…

Toxicological Risk Assessment

A critical component of our service is the assessment of toxicological risks…

Microbiological Safety Evaluation

We assess the microbiological safety of your products to prevent bacterial contamination…

Ingredient Analysis

We conduct a comprehensive analysis of the ingredients used in your cosmetic…

We create Safety Assessment report for your cosmetic product

Upon completing the assessment, we provide a comprehensive Cosmetic Product Safety Assessment Report. This report includes:

Insurance Agency

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Fsat & Easy Process

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Our Compliance Assessment Process

Initial Consultation

Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.

Regulatory Expertise

Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.

Document Review

We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.

Gap Analysis

Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.

Recommendations

Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.

Ongoing Support

Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.

Expertise

Our team of experienced regulatory consultants has an in-depth understanding of global cosmetic regulations and safety standards.

Customized Solutions

We tailor our services to meet your specific product and market needs, ensuring you receive personalized support.

Why choose

Elexes for medical device regulatory & compliance services?

Efficiency

We work diligently to provide timely results, allowing you to bring your products to market quickly

Compliance Assurance

Our thorough assessments and recommendations help you maintain compliance and avoid potential legal issues.

Confidentiality

We treat your product information with the utmost confidentiality and adhere to the strictest privacy standards.

Learn More About Us

Contact us today to learn how our Cosmetic Product Safety Assessment service can ensure the safety and compliance of your cosmetic products, giving you a competitive edge in the market.

Trust Elexes for expert regulatory guidance and safety assessment services you can rely on. Your success is our priority.

Request a Consultation

Our New Product Approval Service Corner

We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -

Global Regulatory Strategies

Creating a new medical product can be challenging in itself. Add a bit of regulatory formalities on top of it and it can become a nightmare for any medical device manufacturer to take care of it all at once. With our experience in working with different regulatory authorities around the globe, you can relax back while we create a successful global regulatory strategy for you through different services like - International regulatory strategies, FDA 513(g) request, product classification, Q-submission and international registration.

Pre-submission Support

Before you even consider submitting a new product for regulatory approval, it is essential that you have a strategy in place for determining the best pathway to get clearances in one-go. The good thing with us is that we will have you prepared for all your regulatory inspections. Right from preparing and conducting pre-submission mock meetings, creating proper regulatory strategy to evaluating ISO 13485 & compliance for your product, we will help you throughout.

Associated Regulatory Authorities.

We’ve More
Then 2563+ Global Clients

Clients Testimonials

Amazing Feedback Say About Services

Tom Birney

CEO Masterlink, Arizona

^“ Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms _“

Diane Bryant

CEO Novasignal, Los Angeles

^“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process. _“

Daniel Kinsey

President ViDava, Florida

^“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice. _“

Linda Pan

Sr. Exe Treedental, Hong Kong

^“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step. _“

Joshua Mink

Manager Outset Medical, California

^“Highly recommend Elexes! They always meet commitments and follow through on action items. _“

Michal Depa

CTO Jana Care, Massachusetts

^“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly. _“

Philip McFerran

MD Blackrock Pharma, England

^“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations. _“

Samip Shah

VP Regulatory AliveCor, California

^“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise. _“

Elizabeth W

Owner Liz Inc., Arizona

^“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time. _“