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India Regulatory Services

CliniExperts - Your reliable partner for Comprehensive Compliance Solutions

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India Regulatory Services

CliniExperts is the catalyst you need to speed up your registration process without worrying about obstacles. Our experience, professional relations understanding and wealth of practical familiarity in the field serve to ease your way through the process. With CliniExperts, you will receive expert advice, 24 hour support, practical guidance and complete technical assistance right from the beginning till the very end of your penetration into the Indian market.

Our Expertise

Our Expertise
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Product Categories

We offer regulatory solutions to Medical Device, Drug, Biologicals, Food, In-vitro Diagnostic and Cosmetics

Product Categories

We Aid Our Clients In All Regulatory Matters

Regulatory bodies are organizations that have the responsibility to scrutinize, steer and manage different sectors in order to ensure the safety of consumers. Such bodies are formulated by the Government in sectors like the drug industry, cosmetic industry and food industry to regulate and control the quality of products that are made accessible to consumers through the market. Brief descriptions of some apex regulatory bodies that govern the Indian markets are:

CDSCO

CDSCO / Zonal CDSCO / State FDA

The Central Drugs Standard Control Organization (CDSCO) is a regulatory body that lays down stringent standards that any drug, medical devices, diagnostic kits, cosmetics, biologicals and vaccines being introduced into the country must meet before being sold in the market. CDSCO has 6 Zonal Offices which are headed by Dy. Drugs Controller (India).

The State Food and Drug Administration has branches in every state that serve to maintain safety and quality standards of food ingredients, food products and imported drugs. This is the highest governing authority for all food and drug clearances needing entry into the country and every state.

One of the key responsibilities of the CDSCO is to grant permits for specific crucial categories of drugs, including blood and blood products, intravenous fluids, vaccines, and sera. It ensures that these specialized drugs meet the necessary standards and are safe for use.

Its regulatory oversight helps to build trust and confidence in the healthcare system.

FSSAI

FSSAI

The Food Safety and Standards Authority of India (FSSAI) is a branch of the Ministry of Health and Family Welfare dedicated to standardizing food products made available in the market through a series of standards that ensure food safety.

It was created under the Food Safety and Standards Act, 2006 to ensure the safety and quality of food products in India.

The primary responsibility of FSSAI is to regulate and supervise the manufacturing, processing, distribution, sale, and import of food items to ensure they meet the defined standards for safety and quality. FSSAI sets food safety standards, and regulates the licensing and registration of food businesses in India.

ICMR

ICMR

The Indian Council of Medical Research (ICMR) is the apex body in India for the formulation, coordination, and promotion of biomedical research. ICMR operates under the Department of Health Research, Ministry of Health and Family Welfare, Government of India.

It is the leading body regulating all medical research in the country. It essays a vital role in the prevention and control of communicable diseases, research regarding toxicology, immunology, reproduction, national medical statistics, food standards and other primary health topics of national interest.

The primary mandate of ICMR is to promote and coordinate medical research activities across the country. It plays a pivotal role in advancing scientific knowledge and addressing health challenges by conducting research, establishing research institutions, and promoting collaboration among researchers, institutions, and industries.

DSIR

DSIR

The Department of Scientific and Industrial Research (DSIR) is an apex body in India that regulates and standardizes topics concerning scientific and industrial sectors of national importance. It also holds the power to grant recognition to public funded universities and is the controlling power over all the IITs and IISCs.

DSIR’s initiatives aim to create an environment conducive to research and innovation, strengthen India’s scientific capabilities, and foster the growth of industrial sectors through technological advancements. By promoting R&D and facilitating technology transfer, DSIR contributes to the overall development of science, technology, and industry in the country.

DGFT

DGFT

The Directorate General of Foreign Trade (DGFT) is an agency of the Government of India that operates under the Ministry of Commerce and Industry.

The primary role of DGFT is to promote and regulate foreign trade in the country. It is responsible for issuing and regulating export-import licenses. It grants various licenses and authorizations, such as Importer-Exporter Code (IEC), Advance Authorizations, Export Promotion Capital Goods (EPCG) scheme, and Duty-Free Import Authorization (DFIA), among others.

It plays a pivotal role in granting licenses and authorizing trade transactions between India and other countries. It also administers various export promotion schemes to support and incentivize Indian exporters. It conducts investigations, audits, and inspections to prevent trade malpractices, monitor export-import transactions, and enforce compliance with trade laws.

NPPA

NPPA

The National Pharmaceutical Pricing Authority (NPPA) is an organization in India that operates under the Ministry of Chemicals and Fertilizers.

The primary objective of NPPA is to regulate and control the prices of pharmaceutical drugs in the country. It has been set up by the government to control and regulate standardized prices for the drugs available in the Indian market.

It ensures that drugs that are needed by masses, and all essential drugs are affordable and easily available throughout the country. It works towards ensuring a balance between the interests of the pharmaceutical industry and the affordability of medicines for patients.

CIBRC

CIBRC

Central Insecticide Board and Registration Committee(CIBRC) is a division of Directorate of Plant Protection, Quarantine and Storage. CIBRC was set up by the Department of Agriculture and Cooperation in order to standardize the quality of insecticides available in the country in order to prevent danger. It ensures that all tenements of the Insecticide Acts and Rules are followed meticulously.

In the Act and the Rules framed there under, there is compulsory registration of the pesticides at the Central level and license for their manufacture, formulation and sale are dealt with at the State level. With the enforcement of the Insecticides Act in the country pesticides of very high quality are made available to the farmers and general public.

CBN

CBN

The Central Bureau of Narcotics (CBN) is an Indian government agency that operates under the Ministry of Home Affairs. It is responsible for the enforcement of the Narcotic Drugs and Psychotropic Substances (NDPS) Act in India.

The CBN issues licenses for the cultivation, production, and manufacturing of narcotic drugs and psychotropic substances for medical and scientific purposes. It conducts investigations, arrests, and seizures related to drug trafficking, production, and distribution.

It plays a vital role in curbing the illicit drug trade, preventing drug abuse, and protecting public health and safety in India.

About CliniExperts

your go-to Regulatory Solutions provider in India!

Established in 2009 by Dr. Ashwini Kumar, CliniExperts is a leading provider of Regulatory and Clinical Research Services. With ISO 9001 and ISO 27001 certifications, we prioritize strict adherence to all the rules and regulations and ensure top-notch standards in our services.

Our team of passionate and skilled professionals collaborates with global companies known for their high-quality products, services, and customer care. We specialize in assisting companies across various sectors, including Medical Devices, In-Vitro Diagnostics, Pesticides, Insecticides, Drugs and more.

At CliniExperts, we live by our belief in unwavering quality and pursuit of excellence. Our zero-tolerance policy for defects creates a flawless regulatory ecosystem, enhancing ease of doing business for our clients.

Choose CliniExperts as your trusted partner for regulatory compliance and streamlined approvals.

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Why Choose CliniExperts?

End-to-End Regulatory Solutions for Domestic and International Markets

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Certifications ISO 9001:2015 and 27001:2013

ISO-9001
ISO_27001
Commitment to Compliance
Commitment-to-Compliance
Team of Expert Professionals
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Our Happy Clients

We collaborate with companies operating in various sectors such as pharmaceuticals, biologics, medical devices, in-vitro diagnostics, food, nutraceuticals, cosmetics, and other related industries.

Testimonials

Nagaraj G P

We’re happy with the Regulatory services rendered and support by CliniExperts for our company as they execute the projects diligently keeping all the regulatory checkpoints in consideration to ensure all activities are carried out ethically by meeting the required MDR 2017 compliances and transparency, which is desired in all the projects. We received the approvals for our IVDs import Licenses in expedited timelines and the entire project was handled professionally and delivered under specified timelines by CliniExperts.

Nagaraj G P

Randox Labortaroies
Mr. Faiyaz

We appointed  Cliniexperts for our Cosmetic registration project for one of our critical products for which we received the registration certificate much  before the timelines committed by the company. The entire project was handled efficiently with sheer professionalism and in our comfort zone . We are very happy with the overall working experience with CliniExperts and will highly recommend their services to everyone.

Mr. Faiyaz

Unity Enterprises
Rajeev Kumar Rattawa

We have been associated with CliniExperts for about a year now for our food products related services for FSSAI compliances and licenses from CliniExperts and are completely satisfied with their performance. Quick turnaround time in responding to queries, meticulous planning in completing the task, alongside the extensive knowledge of the regulations of the entire team is highly appreciable and marks the professionalism and quality driven ethics of the organization. We highly recommend their services as we believe it is best in the industry so far.

Rajeev Kumar Rattawa

Atomy India Pvt ltd
Naavin Changchroenkul

Cliniexperts is one of the best consultants I have come across. It was extremely easy for me to get information from the team I found that the people working on this organization are full of knowledge and professional. Also the speed at which the information is provided was a real take for me to work with them. I will continue to work with them and will not hesitate to recommend them to any one who would need consultancy on regulatory front. It is always pleasure to work with such a professional team.

Naavin Changchroenkul

Suretex Limited
Jayakar Chandran

We have been associated with CliniExperts since 2018 . Quick turnaround time in responding to queries, meticulous planning in completing the task, alongside the extensive knowledge of the regulations of the entire team is highly appreciable and marks the professionalism and quality driven ethics of the organization. The entire team of CliniExperts follow a proactive and collaborative approach keeping abreast with regulatory guidelines , clear communication, and transparent operations . We highly recommend their services as we believe it is best in the industry so far

Jayakar Chandran

Leader Biomedical and Surgicals India Pvt Ltd.
Ajitesh Trehan

We have been professionally associated with CliniExperts for more than 5 years now. They have smoothly sailed us all these years in different projects & this has been possible because of the knowledge & dedication CliniExperts team has in their portfolio. All the best CliniExperts. Keep going.

Ajitesh Trehan

Director – Proficon Medisol Pvt. Ltd.
Radhakrishnan V.K

We have been associated with CliniExperts since 2020 for Cosmetics Product Registration in India.  We are very happy with the way they have handled the registration process!  Their expertise in regulatory affairs, professionalism and commitment to timelines are an asset to any company looking to work with them.  CliniExperts have a team of very efficient, talented and customer-service oriented professionals. Indeed, we have had a great experience with CliniExperts and highly recommend them.

Radhakrishnan V.K

Research & Development Manager, Omniscent Fragrances Fz-llc, Dubai, Uae.
Sathya

We have been associated with CliniExperts for the last 5 years. During this tenure, we have found them very professional in their approach, good understanding of the subject with strong ethical and compliance standards. They adhere to the mutually decided timelines and keep us updated on the project on a regular basis. We thank them for all their support and wish them all the best.

Sathya

Managing Director – South Asia, Galderma India Pvt. Ltd.
Boddu Ganesh

Thank you very much for the superb service solidified on our various regulatory projects. Your knowledge, expertise and skills are the key factors for the successful delivery. CliniExperts got us the approvals for the projects which are very critical. That was fabulous job. We appreciate the efforts taken in delivering the assignments without much delay. Status Update, Documentation and Support rendered while processing the applications were remarkable.

Boddu Ganesh

Dy. Manager-Regulatory Dept, Eisai India, Vizag, AP.
Sunitha

Thankyou very much for the wonderful service rendered on our various regulatory projects. We appreciate the efforts taken in delivering the assignments without much delay. Status Update, Documentation and Support rendered while processing the applications were phenomenal. Your knowledge, expertise and skills are the key factors for the successful delivery. One product registration was really critical. Our product was lying in the port and we were in need of a cosmetic registration urgently to clear the stock. In minimum span of time we got the Registration done and cleared the stock from the port without much demurrages. That was a commendable job.

Sunitha

Conybio Healthcare (India) Pvt. Ltd
Yash Shrivastav

We have had a great experience with CliniExperts. Their expertise in handling the Indian regulatory environment makes them the perfect partner. All our requirements were taken care of swiftly and on time.

Yash Shrivastav

Intercorp Biotech Limited
R.L Goyal

CliniExperts team is efficient, understanding, cooperative with Superchem and FBO’s to attend each requirement and query relating to product approval system as well as regulatory authorities. They are great help to us. Our best wishes for CliniExperts.

R.L Goyal

C.E.O (Superchem Nutri Formulations)
Pawan Shukla

I just want to say Thanks! To the entire CliniExperts team for providing the outstanding support to help us to understand the various Food Regulation & to reply the various FSSAI queries letters for Product approval applications on time. You people are simply great, very alert; very approachable; I’m very fond of your way of working with FSSAI & your scientific justification & literature to resolve the various FSSAI queries professionally. In addition to being very friendly. CliniExperts are simply the Best Regulatory partner anyone can have for various regulatory supports. Once again Thank you to all CliniExperts team for having resolved my FSSAI tricky problems and for your wonderful support.

Pawan Shukla

Regulatory Affair Manager (Valentine Agro Pvt. Ltd.)

Blogs

Complete Procedure to Meet the CDSCO License Mandate of Class C &...

On October 1, 2023, the Medical Device Rule 2017 will go into effect, and manufacturers and importers of Class C&D devices will...

Regulation/Guidelines

October 25, 2023
What penalties are levied in case of Non-Compliance in obtaining Wholesale Drugs?

One must obtain a drug license to launch a business selling drugs or cosmetics. No one can sell drugs or cosmetics without...

Regulation/Guidelines

February 14, 2024
Key factors to keep in mind while getting approval for wholesale drug...

A wholesale drug license is required for manufacturing, distribution, sale, or storage of drugs. The Drugs and Cosmetics Act, 1940 outlines the...

Regulation/Guidelines

February 14, 2024
CPCB Alert – Timely Annual Report to be Submitted by PIBOs to...

The Central Pollution Control Board (CPCB) issued a directive alert for submission of timely annual reports by all Pollution Implementing and Beneficiary...

Regulation/Guidelines

December 5, 2023
Legal Implications of the CDSCO License Update for Class C and Class...

The Central Drugs Standard Control Organization (CDSCO) has announced that effective from the 1st of October 2023, Class C and Class D...

Regulation/Guidelines

September 4, 2023
What is the purpose of CDSCO SUGAM portal registration?

The national regulatory body for regulatory functions and processes in India goes by the name of Central Drug Standard Control Organisation (CDSCO)....

Regulation/Guidelines

July 19, 2023
Registration of Foreign Food Manufacturing Facilities (ReFoM)

Registration of Foreign Food Manufacturing Facilities (ReFoM) intending to export Egg powder; Nutraceuticals; Meat & meat items, including fish, poultry & their...

Regulation/Guidelines

May 2, 2023
API Registrations of Drugs In India

Central Drugs Standard Control Organization (CDSCO) is the regulatory body of India regulating medical devices, drugs, and cosmetics in the Indian market....

Regulation/Guidelines

April 28, 2023
Summary Notes On DTAB (Drug Technical Advisory Board), P1988 FDC’s (Fixed Dose...

The Drugs Controller General of India DCG(I) had taken an action to exclude certain drugs from the need for the safety and...

Regulation/Guidelines

April 17, 2023
How to Apply for an FSSAI License / FSSAI Registration?

FSSAI License is a mandatory document required to carry out food-related business in India. It has a unique fourteen-digit number.FSSAI License is...

Regulation/Guidelines

April 4, 2023
Import In-vitro Diagnostic Medical Devices for Sale or for Distribution in India

To import IVD devices in the indian market, it is important for importers to comprises with all the quality standards and competencies....

Regulation/Guidelines

February 21, 2023
Procedure to Get manufacturing/import license for new Medical Devices India

To manufacture/import those medical devices which do not have predicate devices, one needs to fill out the form MD-26, whose permission is...

Regulation/Guidelines

February 13, 2023
Benefits of the Wholesale Drug License

The State Licensing Authority grants a wholesale drug license to wholesalers who wish to sell, exhibit, stock, or distribute drugs in India.

Regulation/Guidelines

February 2, 2023
Wholesale Drug License – Form, Process, and Required Documents

A wholesale drug license allows the wholesaler to sell, store, exhibit, and distribute drugs in India. However, the applicant must fulfil the...

Regulation/Guidelines

December 16, 2022
Manufacture Class A-B Medical Devices: Who can apply, Forms, Fee, Validity, Timeline

The new Medical Devices Rules, 2017, classify all medical devices into four different categories- Class A, Class B, Class C and Class...

Regulation/Guidelines

October 31, 2022
Integrated Pharmaceutical Database Management System 2.0 (IPDMS 2.0) and the Pharma SahiDaam...

Integrated Pharmaceutical Database Management System 2.0 (IPDMS 2.0) and the Pharma SahiDaam 2.0 App Launched On the Silver Jubilee Celebration of NPPA

Regulation/Guidelines

October 20, 2022
CDSCO Announces Medical Device Classification Pertaining to Hand-held Surgical Instruments for General...

Non-sterile and invasive medical tools commonly used for dissecting, cutting, sawing, drilling, grasping, clamping, clipping, retracting and similar procedures that require no...

Regulation/Guidelines

October 10, 2022
Test License for Medical Devices to Import – Checklist And Necessary Documents

To obtain a test license for importing a medical device, the applicant must submit documents containing a description of the medical device...

Regulation/Guidelines

September 21, 2022
What is Form MD 7 & MD 9, and How To Apply...

Medical devices in India are manufactured under the rules and regulations set by the regulatory authority of India, that is, CDSCO. In...

Regulation/Guidelines

September 8, 2022
ISO 13485 Medical Devices Certification: Medical Device ISO Standards

Medical Device ISO 13485 Certification is a systematic framework for manufacturers, importers and distributors that maintains the quality and standard of regulatory...

Regulation/Guidelines

August 18, 2022

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