New Product Development

Most of the medical equipment manufacturers and companies would agree that regulatory changes is one of the primary challenges they face. With the ever-evolving medical device industry, the regulations are also becoming more gruesome day by day. Getting familiar with all these regulations can become quite overwhelming for any medical device company working on creating a new product. This is why, it is critical to find a professional support to get medical device approval from different regulatory bodies across the globe.

At Elexes medical consulting, we have a team of experts who will guide you through both domestic and international regulations at any phase of your medical device development process. From pre-submission strategies to international submission support, we will hold your hand throughout your new product approval process.

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Welcome To Elexes

Looking for new product approval support?

Look no further!

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.

Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…

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Domestic & International submission

We have an efficient team of professionals who will help you get medical device approval through your choice of regulatory body. Whether it is a domestic or international approval you seek, we will help you get it. Technical documentation, pre-market approval, innovative regulatory pathways, facilitation & interactions with regulatory authorities, we offer a wide range of support to get new product approvals.

Which countries’ do we offer our services in? Check if your target country is on our list

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Expert Regulatory Guidance:

Our team of regulatory consultants possesses a deep understanding of global cosmetic regulations. We keep abreast of evolving guidelines to provide you with the most up-to-date insights.

Precise Labeling Evaluation:

We meticulously review your product labels, scrutinizing every detail to ensure compliance with local and international regulations. From ingredient listings to claims substantiation, we leave no stone unturned.

Why Choose Our Service?

Claims Substantiation:

Making bold claims about your cosmetics? We help you substantiate them with scientific precision, ensuring your marketing messages align with regulatory requirements.

Risk Mitigation:

Our proactive approach identifies potential compliance pitfalls, allowing you to address issues before they become costly setbacks.

Consumer Trust:

Accurate labeling and substantiated claims foster consumer trust. We help you build a brand that stands out for its transparency and commitment to compliance.

Post-submission services

Unlike what you might think, getting clearance/approval for your product is not the final step in the process. You will need to register, list your device and identify the changing and evolving regulations to ensure that your product remains compliant. We will have a dedicated professional assigned to keep a check on the compliance of your medical device post launch.

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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 _“

Huiyou Zhu

CEO TrioWave, California

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

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. _“

Kurt Sysock

CEO Radformation, New York

^“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation! _“

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Your Gateway to Regulatory Excellence

Are you a cosmetics brand striving to navigate the complex landscape of product labeling regulations? At Elexes Regulatory & Quality Consultancy, we understand the pivotal role that accurate labeling and claims play in your cosmetic business's success.

Every cosmetic product needs to be labelled according to the strict regulatory norms and requirements of the desired market. This does not just apply to INCI (ingredients listings), but also to the mandatory items on both primary as well as secondary packaging, claims and the language(s) used on the label.

Insurance Agency

On the other hand denoue with right indignation

Fsat & Easy Process

At vero eos et accu samus dignissimos ducimus

Control Over Policy

Nam libero tempore cums soluta nobis cumque

Save Your Money

Blame belongs those Who duty through weakness

Welcome To Elexes

Our Cosmetic Labeling Review and Claims Service can help you ensure compliance and speed up your cosmetic approval process.

Cosmetic Labeling Review Services

Regulatory Content report (RCR)

For cosmetic companies that are marketing and manufacturing products for multiple countries and markets, it is very easy to lose track and make mistakes in compliance and regulations. This can directly impact the cost and time of launching the product. Based on the PIFs and the assessment conducted by experts at Elexes, we can define the mandatory label content for your product which will be provided to you in the RCR that is regulatory content brief. This RCR can help you navigate all your artwork designs and marketing text strategies for the product.

Design labels efficiently in compliance with regulations

When it comes to cosmetic labeling, each country has its significant requirements. Matching up to those requirements can become a hassle for cosmetic companies. This is where Elexes jumps in. We have experts who will advise you on the requirements per country and will guide you on what needs to be translated, what country roll-out plan should you follow and what labeling strategy you should implement.

Cosmetic Claims

We, at Elexes also help you substantiate your product claims upfront after reviewing your test results and scientific literature further advising you on rewording them if needed. There are many cases in which companies end up making claims which put their product(s) in drug or biologics category which makes the entire process complicated since they have different set of regulatory measures. At Elexes, we ensure that your product rightly categorized and the claims corresponds to the product category we choose. This ensures that the regulatory inspection and approval go as smoothly as possible.

Expert Regulatory Guidance:

Our team of regulatory consultants possesses a deep understanding of global cosmetic regulations. We keep abreast of evolving guidelines to provide you with the most up-to-date insights.

Precise Labeling Evaluation:

Why Choose Our Service?

Claims Substantiation:

Making bold claims about your cosmetics? We help you substantiate them with scientific precision, ensuring your marketing messages align with regulatory requirements.

Risk Mitigation:

Our proactive approach identifies potential compliance pitfalls, allowing you to address issues before they become costly setbacks.

Consumer Trust:

Accurate labeling and substantiated claims foster consumer trust. We help you build a brand that stands out for its transparency and commitment to compliance.

Our Process

Comprehensive Label Review

We conduct a thorough analysis of your cosmetic product labels, assessing ingredient listings, warnings, and formatting.

Claims Assessment

We examine your product claims, ensuring they adhere to regulatory guidelines and have the necessary scientific support.

Regulatory Compliance Check

We cross-reference your labels and claims with local, regional, and international regulations, flagging any potential issues.

Customized Guidance

We provide you with actionable recommendations and solutions to address compliance gaps.

On-Going Support

Our commitment doesn't end with a report. We're here to support you throughout implementation and ongoing compliance monitoring.

With Elexes’s Cosmetic Labeling Review and Claims Service, you gain more than regulatory compliance; you gain a competitive edge. Your customers will trust your products, and you'll have the peace of mind that comes from knowing your brand stands on solid regulatory ground.

Elevate your cosmetic brand with compliant, transparent, and confidently labeled products. Contact us today to discuss how our expertise can benefit your business.

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