CDSCO Authorized Agent Support
BIOLOGICAL
CliniExperts helps you grow in the Indian market by assisting with licensing and registration process. The team also helps by reaching out to distributors and providing logistics. They also guide in pre-certification and post-marketing surveillance processes. We act as an authorized agent for biologics registration and license. Significant issues like delay in customs, inability to change distributors and others will be taken care of by our team.
Authorized Agent For
BIOLOGICAL – Overview
If a foreign company lacks an establishment in India but desires to enter the Indian market, they can appoint an authorized agent. The agent can then handle the registration and marketing of their products in India.
An “Authorized Agent” means a person or entity in India authorized by the foreign company. Authorized agent will be responsible for import and business activities of the foreign company in India. This includes compliance to the provisions of the Drugs and Cosmetics Acts in all respects.
Authorized Agent must possess a valid wholesale license meant for the sale and distribution of products or services in India. They should also be able to file an application to Central Licensing Authority for Biological registration in India.
Who Would Need
An Authorized Agent Service?
Any foreign company who want to capture the Indian market but does not have its business operations or partner in India.
Services CliniExperts Provides As An Authorized Agent
Biologicals are agents extensively used in various aspects of patient care. They are used in diagnostics, therapeutics, preventive care and for improving patient life. Biologicals include serums, vaccines, r-DNA, stem cells, antigens, antioxidants and more.
CliniExperts' professionals enable manufacturers to register, import and distribute biologicals. They ensure that each and every regulation and guideline laid down by the Indian authorities is followed. As biologics authorized agent, we streamline all processes starting from documentation to distribution. We hold a valid Authorized Agent registration certificate that can make your entire experience hassle free. Having been in the field for over a decade, CliniExperts provides you with services like:
Guidance with Registration Process and Application
Obtaining NOC for a global clinical trial
Obtaining Authorization from CDSCO
Obtaining Test License (Pre-Certification)
Post Approval Changes
Marketing Authorization
Clinical Trial Permission depending on Phases of Trials
Responsibilities of
Authorized Agent
An Authorized Agent takes care of all the biological products' Import, marketing, distribution, and sale.
The Authorized Agent must have a valid Wholesale Drug License to conduct the above duties.
Authorized Agent will handle all tasks and responsibilities according to the government's rules and regulations.
The Authorized Agent takes the approval from the MHFW under Form-40 for grant of registration certificate (RC). The validity of the Registration Certificate is for three years.
The agent must pay the necessary RC fees to the Licensing Authority.
The Agent will manage the approval of clinical trials, marketing authorization and submit the application for RC to CLA.
The Agent will be legally responsible for intimating the CDSCO for any changes post approval on the site/drug in the RC.
The Agent will be responsible for issuing of Form-9 to the importers to import the drug on RC. They will also assist in managing adverse reaction reporting and post marketing surveillance.
Essential Tips
Two main requisites while preparing for the process of license application are:
Possession of wholesale license for sale and distribution of biologicals in India
Appointment as an authorized agent
Expert Advise
With respect to import of biologicals, the foreign manufacturer has to submit
Certificate of Pharmaceutical products and WHO-GMP of the finished product.
Power of attorney, allowing authorized agent to market their products in India on their behalf.
Documentary evidence at the time of grant of license and subsequently as and when needed.
Primary Service
CliniExperts offer strategic planning services for product registration. In addition, they also assist in finding distributors and act as an authorized agent as well. Our hand in glove approach ensures that at no point you find yourself battling with any process.
Who Can Apply
The applicant who wishes to store, distribute and sale the drugs in wholesale can apply for wholesale License. The person should be a Registered pharmacist (RP) who have a degree or diploma in pharmacy from a recognized university. Further, arrange one person with same competency for it.
Frequently Asked Questions
Why do I need biological authorized agent support services?
Any foreign brand, manufacturer or distributor of biologicals products has to go through a rigorous registration procedure and approval process. At CliniExperts, we are a one-stop solution for possible issues that might arise during the process of registration and marketing of biologicals in the country. CliniExperts will take care of your biologicals, starting from registration in the Indian market to its sale, distribution and marketing authorization.
What are the benefits of hiring CliniExperts in place of your distributor in India?
Hiring a distributor can be complicated in the initial stages of business. In addition, the inability to change distributors, and their poor reach to the Indian market can be a hassle. In future, if you consider changing your distributor due to any reason, it will be a tedious process. CliniExperts is a leading regulatory and business consultancy in India; foreign companies can quickly register their products under the CliniExperts umbrella. Setting up a business in another country can be tedious, complicated and an expensive affair. CliniExperts is like a one-time investment for your all needs, as it will be a neutral point of contact between you and distributors. Through CliniExperts you can change multiple distributors or choose your distributor based on your specific requirements, as your business expands, instead of hunting for new or more distributors repeatedly. We can provide expertise and help streamline your yearly annual compliances, accounting and penalties. Moreover, we understand the Indian market and its norms and regulations; the CliniExperts team can guide you in keeping up with the latest taxation policies, closure causes and complexities of rules in India.
What additional services CliniExperts is offering along with biologics authorized agent support?
CliniExperts helps its clients by providing assistance and expertise in the following services:
- Obtaining NOC (Form 29) ·
- Approval for Clinical Trials ·
- Expert Marketing business strategy for Biologicals ·
- Obtaining Authorization from CDSCO ·
- Assisting in post-approval changes ·
- Identifying potential distributors area-wise and state-wise to launch your products in India.
- A warehouse and CFA support for the distribution of your product
- Import assistance and customs clearance support [Post-market surveillance and Pre-certification support]
What sales model are CliniExperts offering?
The main focus at CliniExperts will be increasing your reach to the Indian market; we will be a significant neutral and common point of contact for all licenses, registrations, imports, and distribution of your product. In addition, our highly experienced team can provide seamless logistic support and analysis. They will be available round the clock to provide you with optimum services.
What is the legal compliance to opt for these services?
As an appointed Authorized Agent, CliniExperts will be legally responsible for pre-certification and post-marketing surveillance inquiries. Any product recall, adverse drug reaction, or compensation to be made, or legal compliance will be covered by the actual manufacturers to CliniExperts.