Elexes Medical Consulting Pvt Ltd
We are dedicated to the project at hand and have the expertise to quickly address all your regulatory needs. Let us take care of regulations so you can foc
"Every idea is a good idea! What it needs is a strong Regulatory and Quality support to see the light of the day". We are here for bringing new technologies to the market and helping you to ensure the safety and efficacy of the existing ones. Learn how Our Regulatory and Quality services can foster your needs in achieving your mission by saving in timelines and resources at best industry rates.
![Cosmetic Labeling | All about Labeling Requirements & more](https://img3.findglocal.com/483/956/706605044839564.jpg)
When it comes to cosmetic labeling, there is so much to understand from the regulatory perspective. Every regulatory body be it the FDA, EU, or any other has a particular set of requirements when it comes to labeling your cosmetic product.
Here, we have listed all the necessary requirements as per the .
We hope you would find the article helpful.
If you are looking for professional assistance with cosmetic labeling, all you have to do is contact our experts at [email protected], or visit our website elexes.com.
Cosmetic Labeling | All about Labeling Requirements & more What is the FD&C Act & FPLA, how to correctly label cosmetics, Cosmetic labeling requirements, learn it all in this cosmetic labeling guide
![Telemedicine | What it is & its regulatory requirements for approval?](https://img3.findglocal.com/842/303/704103628423039.jpg)
Telemedicine is the latest technological development in the field of medicine. Where it has brought a new age of virtual consultations and remote patient care into picture, it has also introduced many challenges like cyberattcks etc.
Learn all about what is Telemedicine and how its regulatory approval process is different from conventional medicines here๐
Telemedicine | What it is & its regulatory requirements for approval? From what telemedicine are and how regulatory bodies approve them, learn it all here in our blog. Understand the regulatory requirements
![Photos from Elexes Medical Consulting Pvt Ltd's post](https://img5.findglocal.com/527/361/702264505273618.jpg)
We all know how challenging the compliance and regulatory journey could be. Considering these challenges, it is vital to get professional help. Medical device consultants will help you navigate through regulatory compliance, risk assessment, and other challenges that might create roadblock(s) in your approval journey.
Check out this post to learn why bringing an expert consultant on board could be your best move.
Swipe left to know in detail
![FDA 510k Approval | 13 Common Mistakes to Avoid!](https://img4.findglocal.com/234/877/698179612348774.jpg)
Hello, MedTech pros and future healthcare specialists! ๐
Ready to change the game with your medical device? Let's make sure you get that FDA approval first๐ฆ Here are 13 common 510(k) mistakes that could be tricky, but weโve got your back.
๐ฏ Want the full read? Hit that link below!
FDA 510k Approval | 13 Common Mistakes to Avoid! Learn about the 13 common mistakes that one should avoid while filing for 510(k) approval with FDA and speed up the process.
![Things to Consider Before Hiring A Medical Device Consultant!](https://img4.findglocal.com/940/154/694318589401543.jpg)
Confused whether to hire a or notโ Well! Letโs look at what these medical device regulatory and compliance agencies do that makes them valuable for any and all .
From to Interdisciplinary Collaboration, these consultants will offer support at every step of the process.
You can check the complete list ๐ of things that a medical device consultant can do for you here ๐๐ป
Things to Consider Before Hiring A Medical Device Consultant! Learn what makes the medical device consultant best for hiring. Find the checklist here to never be wring with hiring a consultant again.
![Photos from Elexes Medical Consulting Pvt Ltd's post](https://img3.findglocal.com/974/034/690930579740344.jpg)
Defining a medical device classification can always be challenging. However, it is essential for any medical device company to classify its product accurately. You can aptly classify by:
- Verifying definitions
- Understanding objectives
- Evaluating modes of action
- Researching similar devices
- Seeking regulatory guidance
- Conducting thorough risk assessments
- Staying updated
Read more about classification here https://www.elexes.com/is-my-product-a-medical-device/
![Photos from Elexes Medical Consulting Pvt Ltd's post](https://img5.findglocal.com/647/217/690278956472173.jpg)
Letโs explore how FDA is classifying medical devices on the basis of their risk levels: Class I, II, and III. Where class I is the least risk device, class III is the riskiest of them all. Read the complete blog to know more about these classifications.
You can find more details on medical device classification in our blog - https://www.elexes.com/is-my-product-a-medical-device/
![MDR Extension: Navigating the Latest Changes in European Medical Device Regulations - Elexes](https://img3.findglocal.com/396/400/615360633964006.jpg)
๐๐๐ ๐๐ฑ๐ญ๐๐ง๐ฌ๐ข๐จ๐ง: ๐๐๐ฏ๐ข๐ ๐๐ญ๐ข๐ง๐ ๐ญ๐ก๐ ๐๐๐ญ๐๐ฌ๐ญ ๐๐ก๐๐ง๐ ๐๐ฌ ๐ข๐ง ๐๐ฎ๐ซ๐จ๐ฉ๐๐๐ง ๐๐๐๐ข๐๐๐ฅ ๐๐๐ฏ๐ข๐๐ ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐ข๐จ๐ง๐ฌ
The MDR and IVDR aim to improve the safety and performance of medical devices & IVDs, as well as increase transparency and accountability in the industry. The European Commission proposed an extension for the MDR deadline, which was later approved by the European Parliament and the Council of the European Union. The extension was granted to give manufacturers, notified bodies, and other stakeholders more time to prepare for the changes and ensure compliance with the new regulations. Let us look at the revised timeline here.
MDR Extension: Navigating the Latest Changes in European Medical Device Regulations - Elexes Introduction When it comes to placing medical devices on the market in the European Union, the Medical Devices Regulation has taken the role of the Medical Device Directive (93/42/EEC). All prior notices pointed to the 26th of May, 2024 as the last day of the MDR transition phase. However, recently....
![Maximizing Talent Resources through Staff Augmentation - A Case Study - Elexes](https://img4.findglocal.com/760/845/612249507608452.jpg)
๐๐๐ฑ๐ข๐ฆ๐ข๐ณ๐ข๐ง๐ ๐๐๐ฅ๐๐ง๐ญ ๐๐๐ฌ๐จ๐ฎ๐ซ๐๐๐ฌ ๐ญ๐ก๐ซ๐จ๐ฎ๐ ๐ก ๐๐ญ๐๐๐ ๐๐ฎ๐ ๐ฆ๐๐ง๐ญ๐๐ญ๐ข๐จ๐ง - ๐ ๐๐๐ฌ๐ ๐๐ญ๐ฎ๐๐ฒ
Are you looking to set up a procedure for hiring and training for your emerging healthcare organization?
Look no further, Elexes is here to help you. Our dedicated team of Quality professionals with years of experience is ready to support healthcare companies throughout the hiring and training process. If you have any questions, please email us at [email protected].
Maximizing Talent Resources through Staff Augmentation - A Case Study - Elexes Background A manufacturer developing healthcare products planned to expand their existing team for designing, manufacturing, and marketing and sought to register their products in the markets worldwide. However, they were concerned about the description of job requirements, the candidate shortlistin...
![](https://img3.findglocal.com/433/378/611662874333782.jpg)
๐๐ง๐จ๐ฐ ๐๐จ๐ฎ๐ซ ๐
๐จ๐จ๐: ๐๐ง๐๐๐ซ๐ฌ๐ญ๐๐ง๐๐ข๐ง๐ ๐ญ๐ก๐ ๐
๐๐๐ญ๐ฌ ๐๐๐จ๐ฎ๐ญ ๐
๐จ๐จ๐ ๐๐๐๐ข๐ญ๐ข๐ฏ๐๐ฌ
While food manufacturers must add additives to food products as required, however, it is also important to know the regulations applicable to both the additives and ingredients. Did you know not all of these additives are regulated and not all of them are free from the regulations?
Confused? Hereโs a sneak peek.
![Streamlining Supply Chain Efficiency: Lessons learned from a Supplier Audit - Elexes](https://img4.findglocal.com/438/246/611176014382468.jpg)
๐๐ญ๐ซ๐๐๐ฆ๐ฅ๐ข๐ง๐ข๐ง๐ ๐๐ฎ๐ฉ๐ฉ๐ฅ๐ฒ ๐๐ก๐๐ข๐ง ๐๐๐๐ข๐๐ข๐๐ง๐๐ฒ: ๐๐๐ฌ๐ฌ๐จ๐ง๐ฌ ๐ฅ๐๐๐ซ๐ง๐๐ ๐๐ซ๐จ๐ฆ ๐ ๐๐ฎ๐ฉ๐ฉ๐ฅ๐ข๐๐ซ ๐๐ฎ๐๐ข๐ญ
Are you looking to conduct a supplier audit for your organization?
Look no further, Elexes is here to help you. Our dedicated team of auditors with years of experience is ready to support medical device and IVD manufacturers throughout the supplier audit process. Contact [email protected] today!
Streamlining Supply Chain Efficiency: Lessons learned from a Supplier Audit - Elexes Background A medical device manufacturer (legal manufacturer) developing therapeutic lasers and based in the United States had their contract manufacturer based in India. The contract manufacturer was responsible for the development and production of therapeutic lasers as per the service agreement.....
![](https://img5.findglocal.com/116/569/610010391165697.jpg)
๐๐๐ฉ๐ฉ๐ฒ ๐๐๐ฌ๐ญ๐๐ซ 2023
Elexes wishes you all a joyful Easter filled with new beginnings and renewed hope. May this special day bring you happiness and blessings that last throughout the year. Happy Easter 2023!
![](https://img3.findglocal.com/843/515/603982478435155.jpg)
๐๐ฎ๐ญ๐ญ๐ข๐ง๐ ๐ฒ๐จ๐ฎ๐ซ ๐๐๐ฌ๐ญ ๐๐จ๐ฌ๐ฆ๐๐ญ๐ข๐ ๐ฅ๐๐๐๐ฅ ๐๐จ๐ซ๐ฐ๐๐ซ๐
Did you know that the contents of a cosmetics label are subject to regulations?
There is a lot to know about what should and should not be put on the package of a skincare product. Let's take a closer look at the key elements of a cosmetic label.
![Overcoming hurdles of launching an IVD in the European market - Elexes](https://img5.findglocal.com/514/752/603525475147522.jpg)
๐๐ฏ๐๐ซ๐๐จ๐ฆ๐ข๐ง๐ ๐ก๐ฎ๐ซ๐๐ฅ๐๐ฌ ๐จ๐ ๐ฅ๐๐ฎ๐ง๐๐ก๐ข๐ง๐ ๐๐ง ๐๐๐ ๐ข๐ง ๐ญ๐ก๐ ๐๐ฎ๐ซ๐จ๐ฉ๐๐๐ง ๐ฆ๐๐ซ๐ค๐๐ญ
The accuracy and reliability of an In Vitro Diagnostic (IVD) are effectively communicated via the device's labeling. Correct and thorough labeling benefits physicians in making informed decisions about which tests to order and how to interpret the results. For any manufacturer, serious penalties, including fines and legal responsibilities, may occur for not adhering to IVD labeling rules. With an eye on ensuring patient safety, hereโs how Elexes helped an IVD manufacturer to overcome its labeling challenges while designing or updating IVD labels.
Overcoming hurdles of launching an IVD in the European market - Elexes Background An in-vitro diagnostic (IVD) manufacturer was not familiar with the EU regulations and wanted to understand the general requirements that were needed to be fulfilled in order to market their products. The device utilized cardiac enzymes, also referred to as cardiac biomarkers, to identify...
![๐๐๐ฑ๐ข๐ฆ๐ข๐ณ๐ ๐ฒ๐จ๐ฎ๐ซ ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐จ๐ซ๐ฒ ๐๐จ๐ง๐ฌ๐ฎ๐ฅ๐ญ๐ข๐ง๐ ๐ฐ๐ข๐ญ๐ก ๐
๐๐ ๐๐๐ซ๐ฏ๐ข๐๐๐ฌ](https://img3.findglocal.com/542/430/600757655424304.jpg)
"๐๐๐ฑ๐ข๐ฆ๐ข๐ณ๐ ๐ฒ๐จ๐ฎ๐ซ ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐จ๐ซ๐ฒ ๐๐จ๐ง๐ฌ๐ฎ๐ฅ๐ญ๐ข๐ง๐ ๐ฐ๐ข๐ญ๐ก ๐
๐๐ ๐๐๐ซ๐ฏ๐ข๐๐๐ฌโ
Discover how Full-Time equivalent services can provide you with a dedicated regulatory consultant to ensure your organization stays compliant with regulations, streamlines processes, and achieves success. Watch the video to learn more about the benefits of FTE services for your regulatory needs."
Get in touch with Elexes today and explore our FTE services!
๐๐๐ฑ๐ข๐ฆ๐ข๐ณ๐ ๐ฒ๐จ๐ฎ๐ซ ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐จ๐ซ๐ฒ ๐๐จ๐ง๐ฌ๐ฎ๐ฅ๐ญ๐ข๐ง๐ ๐ฐ๐ข๐ญ๐ก ๐ ๐๐ ๐๐๐ซ๐ฏ๐ข๐๐๐ฌ Discover how Full-Time equivalent services can provide you with a dedicated regulatory consultant to ensure your organization stays compliant with regulation...
![How to get regulatory approval for a Triage Software? - Elexes](https://img5.findglocal.com/548/180/600182605481809.jpg)
๐๐จ๐ฐ ๐ญ๐จ ๐ ๐๐ญ ๐ซ๐๐ ๐ฎ๐ฅ๐๐ญ๐จ๐ซ๐ฒ ๐๐ฉ๐ฉ๐ซ๐จ๐ฏ๐๐ฅ ๐๐จ๐ซ ๐ ๐๐ซ๐ข๐๐ ๐ ๐๐จ๐๐ญ๐ฐ๐๐ซ๐?
Would you like to place your device in the US market?
Elexes can be of assistance to you. Our hardworking team has years of experience in helping customers through this process. Please get in touch with us at [email protected] so we can examine your equipment in accordance with FDA guidelines and walk you through the necessary steps further.
How to get regulatory approval for a Triage Software? - Elexes Radiological computer-assisted triage and notification software is a form of image processing software. Based on computer-assisted image analysis done by the device, the device alerts a predefined list of doctors when time-sensitive radiological medical images are available for examination. Using th...
๐๐ฅ๐๐๐ญ๐ซ๐จ๐ง๐ข๐ ๐๐ฎ๐๐ฅ๐ข๐ญ๐ฒ ๐๐๐ง๐๐ ๐๐ฆ๐๐ง๐ญ ๐๐ฒ๐ฌ๐ญ๐๐ฆ (๐๐๐๐)
โ๐๐ง๐ฅ๐จ๐๐ค ๐ญ๐ก๐ ๐ฉ๐จ๐ฐ๐๐ซ ๐จ๐ ๐๐๐๐!โ
Discover how implementing an electronic Quality Management System can streamline processes, enhance patient safety, and ensure regulatory compliance in your healthcare organization. Watch the video to learn more.
Get in touch with Elexes today and know more!
๐๐ฎ๐๐ฅ๐ข๐ญ๐ฒ ๐ข๐ฌ ๐๐ญ ๐ญ๐ก๐ ๐ก๐๐๐ซ๐ญ ๐จ๐ ๐ก๐๐๐ฅ๐ญ๐ก๐๐๐ซ๐!
In our latest video, we explore the importance of having a robust Quality Management System in place for the healthcare sector. Learn how a QMS can help you ensure patient safety, comply with regulations, and improve your overall operations. Watch now and discover how to take your quality to the next level with Elexes!
Get in touch with Elexes today and know more!
![Entering into the US Market with an Ultrasound Bronchoscope vs. an Ultrasound for breast cancer detection - Elexes](https://img3.findglocal.com/589/911/596009555899114.jpg)
๐๐ง๐ญ๐๐ซ๐ข๐ง๐ ๐ข๐ง๐ญ๐จ ๐ญ๐ก๐ ๐๐ ๐๐๐ซ๐ค๐๐ญ ๐ฐ๐ข๐ญ๐ก ๐๐ง ๐๐ฅ๐ญ๐ซ๐๐ฌ๐จ๐ฎ๐ง๐ ๐๐ซ๐จ๐ง๐๐ก๐จ๐ฌ๐๐จ๐ฉ๐ ๐ฏ๐ฌ. ๐๐ง ๐๐ฅ๐ญ๐ซ๐๐ฌ๐จ๐ฎ๐ง๐ ๐๐จ๐ซ ๐๐ซ๐๐๐ฌ๐ญ ๐๐๐ง๐๐๐ซ ๐๐๐ญ๐๐๐ญ๐ข๐จ๐ง
Explore the challenges and opportunities Elexes faced in bringing innovative ultrasound bronchoscope and ultrasound for breast cancer detection to the US market, and how we overcame them to achieve success. Elexes' journey serves as a testament to the power of perseverance and strategic planning in the healthcare industry. For questions and comments please feel free to contact us at [email protected]
https://lnkd.in/gTVqC4SZ
Entering into the US Market with an Ultrasound Bronchoscope vs. an Ultrasound for breast cancer detection - Elexes Background A medical device company was looking to understand the FDA classification and regulatory framework that is needed to be considered for an Automated Breast Ultrasound (ABUS). The company wanted to engage a qualified and skilled team to help them with various problems that they were facing....
โ๐๐ซ๐ ๐ฒ๐จ๐ฎ ๐ซ๐๐๐๐ฒ ๐ญ๐จ ๐ญ๐๐ค๐ ๐ญ๐ก๐ ๐๐ข๐ซ๐ฌ๐ญ ๐ฌ๐ญ๐๐ฉ ๐ญ๐จ๐ฐ๐๐ซ๐๐ฌ ๐ ๐ฌ๐ฎ๐๐๐๐ฌ๐ฌ๐๐ฎ๐ฅ ๐๐ฎ๐๐ฅ๐ข๐ญ๐ฒ ๐๐๐ง๐๐ ๐๐ฆ๐๐ง๐ญ ๐๐ฒ๐ฌ๐ญ๐๐ฆ ๐ฐ๐ข๐ญ๐ก ๐๐ฅ๐๐ฑ๐๐ฌ?โ๐
In our latest video, we break down the key steps involved in setting up a QMS implementation, from establishing a framework to monitoring and improving your processes. Learn from our experts and gain insights on how to set your organization up for success. Watch now and get started on your QMS journey with Elexes!
Get in touch with Elexes today and know more!
![](https://img3.findglocal.com/291/944/592472902919446.jpg)
๐๐จ๐ฐ ๐ฐ๐๐ฅ๐ฅ ๐๐จ ๐ฒ๐จ๐ฎ ๐ค๐ง๐จ๐ฐ ๐๐๐จ๐ฎ๐ญ ๐ญ๐ก๐ ๐ข๐ง๐ ๐ซ๐๐๐ข๐๐ง๐ญ๐ฌ ๐ข๐ง ๐ฒ๐จ๐ฎ๐ซ ๐๐จ๐ฌ๐ฆ๐๐ญ๐ข๐๐ฌ?
Someone rightly said, โGood food depends almost entirely on good quality and the right level of ingredientsโ. This holds true not just for food but also for drugs, cosmetics, and biologics in order to get the best results in the safest manner. If you are a cosmetic manufacturing company, and developing products, it is important for you to know your ingredients and make sure they are compliant with the FDA-prescribed levels. Feel free to reach out to Elexes to get your cosmetics ingredient list reviewed.
๐๐๐ฉ๐ฉ๐ฒ ๐๐ง๐ญ๐๐ซ๐ง๐๐ญ๐ข๐จ๐ง๐๐ฅ ๐๐จ๐ฆ๐๐ง'๐ฌ ๐๐๐ฒ 2023!
Elexes wishes you all a Happy International Womenโs Day! We are proud to celebrate the incredible women who make our team a success. Your intelligence, creativity, and perseverance continue to inspire us all. Keep shining! ๐
![Companion Diagnostics (CDx): The future of safe and effective therapies! - Elexes](https://img4.findglocal.com/666/958/588304826669587.jpg)
๐๐จ๐ฆ๐ฉ๐๐ง๐ข๐จ๐ง ๐๐ข๐๐ ๐ง๐จ๐ฌ๐ญ๐ข๐๐ฌ (๐๐๐ฑ): ๐๐ก๐ ๐๐ฎ๐ญ๐ฎ๐ซ๐ ๐จ๐ ๐ฌ๐๐๐ ๐๐ง๐ ๐๐๐๐๐๐ญ๐ข๐ฏ๐ ๐ญ๐ก๐๐ซ๐๐ฉ๐ข๐๐ฌ!
Want to place your Companion Diagnostic device in the US and international markets?
Elexes is here for your support. Each member of our diligent team has years of experience guiding clients through this process. To get your equipment and therapeutic products reviewed for compliance with applicable regulations, write to us at [email protected] and we'll be happy to assist you.
Companion Diagnostics (CDx): The future of safe and effective therapies! - Elexes A Companion Diagnostic (CDx) Device is often an In-Vitro Diagnostic (IVD) device that specifies the conditions for use of another product, like a drug or a biologic. A companion diagnostic may ensure the safety and effectiveness of a product. A CDx falls under the subset of biomarker-oriented testin...
![10 tips to make your next Grant Application a success! - Elexes](https://img3.findglocal.com/674/261/587574586742611.jpg)
10 ๐ญ๐ข๐ฉ๐ฌ ๐ญ๐จ ๐ฆ๐๐ค๐ ๐ฒ๐จ๐ฎ๐ซ ๐ง๐๐ฑ๐ญ ๐๐ซ๐๐ง๐ญ ๐๐ฉ๐ฉ๐ฅ๐ข๐๐๐ญ๐ข๐จ๐ง ๐ ๐ฌ๐ฎ๐๐๐๐ฌ๐ฌ!
Grant applications must be viewed as projects with a clear deliverable or goal in order to get the requested funding. Projects must produce measurable results in order to receive financing. Determine your proposalโs hook โ the essential element โ and then tell a compelling story that connects each experiment to your core goals. A carefully crafted, organized, and packed grant proposal is one that will be accepted. If you want to get your grant proposal approved, Elexes is here to help you out. Elexes with an expert set of grant authors and reviewers can help you compose and review an effective grant proposal. Feel free to contact us at [email protected] for your next grant application!
10 tips to make your next Grant Application a success! - Elexes A grant proposal is a set of documents that are submitted to a company with the specific goal of receiving grants for a project. The process of drafting an effective grant proposal starts with a concept. To convince others to support your project, it is crucial to clarify the ultimate goal and purpo...
![Importing Cosmetic into the US? This is what you need to know! - Elexes](https://img5.findglocal.com/345/776/587089713457765.jpg)
๐๐ฆ๐ฉ๐จ๐ซ๐ญ๐ข๐ง๐ ๐๐จ๐ฌ๐ฆ๐๐ญ๐ข๐ ๐ข๐ง๐ญ๐จ ๐ญ๐ก๐ ๐๐? ๐๐ก๐ข๐ฌ ๐ข๐ฌ ๐ฐ๐ก๐๐ญ ๐ฒ๐จ๐ฎ ๐ง๐๐๐ ๐ญ๐จ ๐ค๐ง๐จ๐ฐ!
Before importing cosmetic items into the US, what should manufacturers or distributors bear in mind? If you are an importer or distributor of a cosmetic product it is vital for you to know FDAโs critical checkpoints for safety and suitability. Elexes is here to help you understand the requirements for importing your cosmetics into the US.
Importing Cosmetic into the US? This is what you need to know! - Elexes What are cosmetics? Cosmetics are substances that are applied to the human body (except pure soap) to enhance beauty, cleanse, make it more appealing, or transform its appearance. They have no physiological impact on the body. Legally, a cosmetic will also be considered a drug, if it intends to alte...
![How are Dietary Supplements regulated in the US? - Elexes](https://img5.findglocal.com/045/534/583780540455349.jpg)
How are Dietary Supplements regulated in the US?
Are you a company developing, distributing, manufacturing, packaging, or labeling dietary supplements? You must be aware and be in compliance with the necessary regulations and requirements to avoid any product recalls, suspension of registration, warning letters, or other adverse actions from the regulatory authorities. Contact us today at [email protected] to learn more about what requirements are applicable to your dietary supplement and how to comply with them.
How are Dietary Supplements regulated in the US? - Elexes What are Dietary Supplements:ย Dietary supplements are additions to the standard diet which are quite distinct from the ingredients found in conventional foods. The use of dietary supplements has witnessed an upsurge in mass consumption over the past several years, as many people have made staying ...
![Grant Process - All you need to know! - Elexes](https://img3.findglocal.com/720/127/582987907201279.jpg)
Grant Process โ All you need to know!
Grants can take your organization closer to achieving your goals and making a real difference. However, a company should have a realistic grasp of the grant process, as well as the time and resources necessary to submit a competitive proposal. It can ensure that the right personnel is involved in this without compromising the existing operations at the company.
Elexes is here to help you in these areas. Our dedicated team has years of experience in supporting our clients in acquiring grants. Please contact us at [email protected] to let us help you gain the funding you need for your endeavors.
Grant Process - All you need to know! - Elexes A grant is often given to an organization by a foundation, company, or governmental entity and is defined as โa financial donation provided to support a person, organization, project, or program.โ. Grant money should account for 10% โ 20% of your overall organization budget, depending on the s...
![Biologics, their Unique Characteristics, Applicable Requirements and Regulations - Elexes](https://img5.findglocal.com/058/958/582438220589581.jpg)
Biologics, their Unique Characteristics, Applicable Requirements, and Regulations
Given the complexity of a Biologics product and its corresponding regulatory submission (BLA), it is of essence to involve the FDA at the right stage of product development and to discuss the validation plan before companies submit the application. The right extent, presentation, and type of information submitted in a licensing application of a BLA go a long way in getting timely approval. For any questions related to your upcoming biologics product please feel free to write to us at [email protected].
Check out our Article: https://lnkd.in/ggUugd2s
Biologics, their Unique Characteristics, Applicable Requirements and Regulations - Elexes The market for biologics is expanding, and it is foreseen that it will grow at a Compound Annual Growth Rate (CAGR) of 9.22% during the subsequent five years. The COVID-19 pandemic had a considerable effect on the market, and there was a massive demand for biologics, which significantly fueled the m...
Exempt but not exempt
With the increasing compliance burden on medical device companies, often companies are relieved and happy by discovering that they are exempt from regulatory requirements. However, in this state of elation, companies often forget, until it's too late, that there may be several other requirements that may apply to them, especially the Good Manufacturing Practices (GMP) or Quality Management System (QMS) requirements. It is not pleasant to find out about what requirements apply to you only in an inspection from the FDA or any other regulatory body. Contact us to find out more about the comprehensive list of requirements that you should consider and stay ready for any inspection.
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Villa No. 677, Adarsh Palm Retreat, Adarsh Colony, Bellandur, Bangalore/
Bangalore
560103
Opening Hours
Monday | 8:30am - 7:30pm |
Tuesday | 8:30am - 7:30pm |
Wednesday | 8:30am - 7:30pm |
Thursday | 8:30am - 7:30pm |
Friday | 8:30am - 7:30pm |
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