New Product Development

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.

On the other hand denoue with right indignation

At vero eos et accu samus dignissimos ducimus

Nam libero tempore cums soluta nobis cumque

Blame belongs those Who duty through weakness

Welcome To Elexes

Looking for new product approval support?

Look no further!

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

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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