CDSCO Medical Device Registration

Our seamless CDSCO medical device registration service helps to make a welcome move into the Indian market with your groundbreaking medical devices. Time to say goodbye to complexities and start a stress-free journey for your innovation to thrive.

CDSCO Cosmetics Product Registration

Excited to launch your cosmetics product in India but worry about the registration process? Take a deep breath and access our CDSCO Cosmetics Product Registration services. Let your dreams flourish in the Indian beauty landscape!

Get Drugs License By Dueran consultant

Your Partner in Drug Regulatory Consulting. Specializing in a Spectrum of Licenses – Import and registration of Drugs and product permissions of New drugs, investigational new drugs, Subsequent New Drugs, Fixed Dose Combination, Manufacturing licence and many more. Navigating Regulatory Landscape with Precision and Expertise."

Unlock Your Path to Success with Dueran Consultancy Services!

Navigate the complexities of In Vitro Diagnostic licensing with ease. Consult with us for seamless regulatory guidance and compliance."Your success story begins with our regulatory insight and guidance."

Import Veterinary Drug Licensing

Navigate Veterinary Regulations Seamlessly with Expert Veterinary Drug License Consultation Services – Ensuring Compliance, Ensuring Care."

Expanding With Every CDSCO Registration

We Know What We Are Offering To Our Client

We are a trusted regulatory solutions provider, offering unparalleled support to our clients to make their CDSCO License journey hassle-free in different industry verticals. Our seasoned regulatory professionals offer end-to-end assistance in the registration process for Drugs, Medical devices, Biologicals, Diagnostic kits, Veterinary, and Cosmetics.

While converting every application to regulatory approval, we get wonderful opportunities to learn the depth of prevailing regulations and compliances. Our meticulous attention to detail and regulatory standards help us to mitigate the risks of Non- Compliance and provide the best result to our clients.

Our Regulatory Services

Explore Our Cutting-Edge Regulatory Intelligence Solutions

Drugs

From top to bottom, we assist you to get Drug Manufacturing licenses, Import licenses, Licenses for Fixed Dose Combinations (FDC), New Drugs, Subsequent New Drugs, Test Licenses, Dual Use NOC, Clinical trials, and more.

Biological

Under biological regulatory services, our team helps you to get successful registration, Import license, Test license, and more.

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Medical Device

we offer customized regulatory solutions for a compulsory license of Notified & Non-Notified Medical Devices, Voluntary Registration of Medical Devices of Class A, B, C, and D, New Medical Device Registration.

In Vitro Diagnostics

Under CDSCO registration, you can manufacture, sell, and import IVD devices. With proactive regulatory services, smoothen your registration for IVD.

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Cosmetics

Whether you are registering for cosmetics as an importer or manufacturer, we let you make successful registration without creating any chaos.

Veterinary

We render cutting-edge regulatory services and solutions to bring new veterinary drugs or vaccines into the market with CDSCO License.

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Vital Aspects of CDSCO License

Know how to process A New Drug Application in Indian Market

Before diving into the landscape of CDSCO licensing and regulatory compliance, you must understand the regulatory framework. Meeting the regulatory requirements is a time-consuming task and prone to errors if you fail to handle them with utmost care. From initial assessment and documentation to submission and follow-ups, a streamlined process must be taken care of. As registered and trusted CDSCO registration consultants, we offer 360 degrees assistance to our clients and let them drive their business forward. Therefore, we let you understand the primary aspects of the CDSCO License.

The Drugs and Cosmetics Act, 1940

Under this act, the Indian government regulates the manufacturing, import, distribution, and sales of Drugs, Cosmetics, Medical Devices, and In- Vitro Diagnostics to ensure their safety and effectiveness.

Drugs Controller General of India (DCGI)

As a head of CDSCO, DCGI control over the import of drugs, approval of new drugs and clinical trials, meetings of the Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licenses as Central License Approving Authority.

SUGAM Online Licensing

SUGAM is an e-Governance system, specially designed to administer various functions that include approval of New Drugs, Clinical trials, Medical devices, IVD, Vaccines, and Cosmetics. It is controlled by CDSCO.

CDSCO Manufacturing License

Whether you seek a medical device or drug manufacturing license, you must understand the intricacies of the complete process and approach CDSCO and State Licensing Authorities for approval.

(NSWS) The National Single Window System

National Single Window System is an online tool to help you find and apply for approvals based on your business needs. The KYA module provides information for 32 central departments and 32 states.

Testimonial

The Main Reason For Your Choice Is Our Best Service

Our experience with Durean Consultant has been outstanding. We connected with the company to get approval for manufacturing a new drug. Their support and knowledgeable guidance have saved us significant time. Their professionals have given us peace of mind, knowing that we are following the government regulations while applying for the drug manufacturing license. We are grateful for their ongoing support and highly recommend their regulatory services.

Sandeep Vij

Knox Baddi

Choosing a Durean consultant for our cosmetics registration was the best decision we made. The comprehensive and in-depth knowledge of India’s regulations for cosmetics was amazing. Their expertise in the field ensured that our products met all necessary requirements. We are thankful for their customized approach and prompt support that gave us the confidence to launch our products in the market successfully.

Jenill D. Vadera

Vanity Group

We have been connected with Dueran Consultant for about a year now. We approached them for our medical device registration and are completely satisfied with their performance. Their team is very helpful and follows strict professionalism when it comes to handling projects. Their meticulous planning and vast knowledge help us to manage everything in minimum time. We highly recommend their services for getting excellent regulatory solutions in India..

Anuj Sharma

Sonotech, Mumbai

Being busy with our product marketing and vendor distribution, we did not have enough time to handle the complexities of regulatory compliance for our cosmetic registration. Thankfully, we found the Dueran Consultant and their experts guided us every step of the way. Their invaluable advice streamlined our processes and allowed us to understand the ever-changing landscape of regulations. Highly appreciable and recommended for all.

Sabah Afroze

Proprietor

It is overwhelming to share our work experience with a Dueran Consultant. Their team not only helped us with regulatory compliance but also went beyond our expectations in terms of project management. We appreciate their professionalism, reliability, and commitment to excellence, ensuring the best regulatory solutions to loan licenses for drug manufacturing in India. Highly recommended.

Harish

Universal Twins labs

Convert Applications to Approval and Build relationships

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Frequently Asked Questions (FAQ)

As National Regulatory Authority for Indian Pharmaceuticals and medical devices, CDSCO is responsible for New Drugs, Clinical trials, Medical devices, IVD, Vaccines, and Cosmetics under the Drugs and Cosmetics Act, 1940, and Drugs and Cosmetics Rules, 1945. There are certain steps you should follow to apply for a CDSCO certificate online:

Visit the CDSCO registration portal and click on the Login/Sign up bar (at the left corner)
If you don’t have an account, click to “Sign Up Here” and select the purpose of Registration purpose.
Click on to drop-down, select the option that defines your purpose of registration, and click on the “Submit” button.
A registration form will open. Once you fill out the form completely, click the “submit” button. A confirmation mail will be sent to your registered email id for verification.

Under CDSCO, the Drugs Controller General of India (DCGI) plays a vital role in the approval of the Import of all Devices and manufacturing of certain medical devices. The manufacturing, sale, import, and distribution of medical devices in India are controlled under the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and New Medical Devices Rules 2017.

There are various types of drug licenses issued by the Central Drugs Standard Control Organization and State Directorate of Drugs Control: Retail, Wholesale, Manufacturing, and Import License.

Retail Drug License: Required to Sell Drugs on a Retail basis
Wholesale Drug License: Required to sell drugs on a wholesale basis.
Drug Manufacturing License: Issued to manufacture drugs under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.
Import License: Require to import Medical Devices, IVD, Drugs, Cosmetics, Biological, and Veterinary under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.

Under the Cosmetics Rules 2020, the following license is required to import cosmetics in India:

Application in Form COS-01: Required for a registration certificate for import of cosmetics into India.
Application in Form COS-04: Required for Import Registration Number for Import of already registered cosmetics.

CDSCO Medical Device Registration

CDSCO Cosmetics Product Registration

Get Drugs License By Dueran consultant

Unlock Your Path to Success with Dueran Consultancy Services!

Import Veterinary Drug Licensing

We Know What We Are Offering To Our Client