Pharma Licensing Services India

We will help in the portal registration, preparation and filing of the applications till the grant of license.

Talk with our Experts

 

 

Central Drugs Standard Control Organization (CDSCO), the Government of India Drug Regulatory Agency has come up with a national portal for filing of applications for licenses/ certificates for manufacturing, marketing and sales for Drugs and Cosmetics. This was the need of the hour to bring uniformity, traceability and accountability in the evaluation and disposal procedure of such an application for issuance of licenses/certificates across the country for the benefit of all the stakeholders. With the launch of this portal, India will have a uniform online drug licensure procedure. The Online National Drug Licensing System portal has been developed by CDAC in coordination with CDSCO & States. It has been made functional for testing with effect from 31st March, 2021 for validation of the system which can be accessed through https://statedrugs.gov.in. The system will be shifted from validation mode to operational for all purposes w.e.f. from 15th April, 2021. Our team of experts who are well versed with the application process shall help in portal registration, preparation and filing of the applications, answering the queries etc. We follow up the application till the grant of license.

medicing manuacturing

WHAT WE DO...

We offer a variety of services to our clients including

Drug Manufacturing License

India has a federal structure, so is the drug licensure procedure. Drug licensing is the responsibility of the State Licensing Authority and/or Central Licensing Authority. India has adopted an online licensing system. Our team of experts who are well versed with the application process shall help in portal registration, preparation and filing of the applications, answering the queries etc. We follow up the application till the grant of license.

Retail and Wholesale License

We also support the firms who intend to open retail and wholesale offices in the country. We support in preparation and filing of the applications, answering the queries etc. We follow up the application till the grant of license. 

100+

Number of Clients

500+

Number of Products Licensed

250+

Number of Applications Processed

100%

Approval rate

OUR Clients

What are our clients are saying about us?

WHAT THEY SAY...

What are our clients are saying about us?

Leeford Healthcare Limited

API First has become our single point contact for resolving all our regulatory issues. The camaraderie they enjoy with our staff has made the job easy for us. The team at API First knows their job well and are extremely professional in approach. Team API First really functions as an extension of our in-house team rather than an external support. It’s this type of collaboration and pharmaceutical expertise that’s make them stand apart from other consulting firms. The team at API First is highly knowledgeable and responsive. They provide a very quick turnaround time between discussion and results. API First has time and again proved to a useful resource for us and supports well in handling regulatory issues of our vast portfolio. Keep up the good work Team API First!

Amit Gupta
Managing Director / Leeford Healthcare Limited

Logos Pharma

We had been interacting with the team API First for quiet sometime. They have encouraged us to venture into new drug approvals. New drug had been an unknown territory for us. Team API First has a passion for, and comprehensive understanding of, every single aspect of New Drug approval in India. Their approach, right from strategizing to filing of application till the final approval is remarkable and contagious. Their suggestions and contributions are extremely helpful; but, most significantly, they train, motivate and instil a confidence among us to achieve something which was considered difficult if not impossible. We wish success for API First in their future endeavours.

Ankur Gupta
Director / Logos Pharma
adley group

Adley Group

Team API First has been an invaluable resource, providing support and directions for getting approval of new drugs and other regulatory permissions. They build strategies backed by data which is an important aspect while planning for new drug launches. The commitment level is exemplary. The entire team is transparent and provides guidance from the product selection to the final approval. Team API First is resourceful, knowledgeable and is expert at regulatory laws and approval processes applicable in the country.

Rahul Batra
Director / Adley Group
theon

Theon Pharma

API First has been instrumental in rekindling our interest in New Drug approval in India. The clarity of pathway and transparency in approach for regulatory filings has made API First our formidable partner. Team API First has always been responsive and they never shy away from replying to any sort of information sought from them. They regularly update about the new developments and regulations in the field of drug manufacturing. The team API First is experienced, knowledgeable, result-oriented, committed and professional in their approach about execution of the project. Their expertise & regulatory knowledge puts them on par with other globally recognized regulatory consultants. Highly recommended! I wish API First best wishes in their future endeavors!

Amit Bansal
Director / Theon Pharma

GET IN TOUCH...

To arrange a consultation or workshop, send us a message.

Contact Us

Other Related Services..

Pharma Regulatory Services

Pharma GMP Services

Pharma Distribution Services

Logo PNG

API First is a team of regulatory experts who are well versed with the nuances of the regulatory filing and subsequent approval processes of drugs in India as well as other regulatory countries. The team of experts have a vast experience with the drug approval process in India.