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Comprehensive Regulatory, Compliance, and Clinical Trial Solutions in India

CliniExperts is your one stop solution for guiding you through the complex world of Healthcare Compliance, Regulations, and Clinical Trials.

For Importer

biological

Form 40, 41

BIOLOGICAL

Biological Registration Certificate for Importers in India

For Importer

Medical Device

Form MD 14, MD 15

MEDICAL DEVICE

Import License for Medical Devices in India

For Importer

IVD

Form MD 14, MD 15

IN-VITRO DIAGNOSTIC

Import License For In-Vitro Diagnostic Kits in India

For Importer

cosmetic

Form Cos 1, Cos 2

COSMETIC

Cosmetic Registration Certificate for Importers in India

For Importer

Medical Device

Form MD 16, MD 17

MEDICAL DEVICE

Test License to Import Medical Devices in India

For Importer

biological

Form 8, 9, 10

BIOLOGICAL

Biological Import License in India

For Importer

bis certification

Form V

BIS CERTIFICATION

BIS Certification for Foreign Manufacturers in India

For Importer

Medical Device

MEDICAL DEVICE

Authorized Agent Support in India

For Importer

IVD

IN-VITRO DIAGNOSTIC

Authorized Agent Support in India

For Importer

Drug

DRUG

Authorized Agent Support in India

For Importer

biological

BIOLOGICAL

Authorized Agent Support in India

For Manufacturer

Drug

Form CT 12, CT13, CT 14, CT 15, 29, 30

DRUG

Test License to Manufacture Drug in India

For Manufacturer

Drug

Form 11, 12, CT-16 & CT-17

DRUG

Test License to Import Drug in India

For Manufacturer

Medical Device

Form MD 3, MD 5

MEDICAL DEVICE

Permission to Manufacture Class B Medical Devices

For Manufacturer

Medical Device

Form MD 7, MD 9

MEDICAL DEVICE

Permission to Manufacture Class C & D Medical Devices

For Manufacturer

Medical Device

Form MD 4, MD 6

MEDICAL DEVICE

Retention of Loan Manufacturing License for Class A & B Medical Devices

For Manufacturer

cosmetic

Form Cos 5, Cos 6, Cos 8, Cos 9

COSMETIC

Cosmetic Manufacturing License in India

For Manufacturer

Medical Device

Form I, V

MEDICAL DEVICE

CRS for Domestic Manufacturer for Electronic and IT Products

For Manufacturer

Drug

Form 24, 25

DRUG

Permission to Conduct Clinical Performance Evaluation

For Manufacturer

food

Form B, Form C

FOOD

FSSAI License for Food Supplements and Nutraceuticals

For Manufacturer

food

FOOD

FSSAI Compliance - For Food Supplements & Nutraceuticals

For Manufacturer

Medical Device

Form A, B

MEDICAL DEVICE

Pre-Conception & Pre-Natal Diagnostic Techniques in India

For Manufacturer

Medical Device

Form 19, 20B, 21B

MEDICAL DEVICE

Wholesale Medical Device License in India

For Manufacturer

Drug

Form 19, 20B, 21B

DRUG

Wholesale Drug License in India

For Manufacturer

biological

Form 19, 20B, 21B

BIOLOGICAL

Wholesale Biological License in India

For Manufacturer

Medical Device

Form I , II

FUNCTIONAL FOOD

Non Specified Product / Ingredient Approval in India

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Our Regulatory and Compliance Services in India

CliniExperts specializes in providing comprehensive 360-degree regulatory and compliance services in India. Navigating the complex journey from concept inception to product approval can be daunting, especially in the face of stringent regulations. We offer a cost-effective solution to streamline this process. With deep expertise in the intricacies of development, testing, approval, manufacturing, commercialization, and post-marketing surveillance, we provide you with a strategic advantage. Trust us to simplify your regulatory path to success in India. Read More

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Medical Device

Medical Device

Regulatory Requirements and guidance for Medical Devices

End to End Regulatory Support in

  • Registration
  • Import License
  • Manufacturing License
  • Performance Evaluation
  • ISO 13485 and QMS etc.

Importer

drug

Drugs

Guiding and assisting through the maze of Drug Regulations

End to End Regulatory Support in

  • New Drug Approval
  • Subsequent New Drug Approval
  • Test Licenses
  • Post Approval Changes
  • BE NOC, etc.

Manufacturer

IVD

IVD

Navigating and aiding in the complex world of regulatory requirements.

End to End Regulatory Support in

  • Registration
  • Import License
  • Manufacturing License
  • Performance Evaluation
  • ISO 13485 and QMS etc.

Importer

food

Food

Information and assistance on regulatory compliance for Food products.

End to End Regulatory Support in

  • FSSAI License or Registration
  • Compliance
  • Claim Approval
  • Non-Specified Food Compliance
  • Function Foods approvals and compliance

Importer

Manufacturer

biological

Biologicals

Guiding and assisting through the maze of regulations

End to End Regulatory Support in

  • Registration of biologicals
  • Import license
  • Test license
  • Export NOC
  • CLAA, LVP, Serums, NOC for Vaccines, etc.

Importer

Manufacturer

cosmetic

Cosmetics

A guiding hand amidst regulatory intricacies for your cosmetic products.

End to End Regulatory Support in

  • Manufacturing license
  • Cosmetic registration and approval
  • Labeling assistance,
  • Testing
  • Cosmetic Product Compliance etc.
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Authorized Agent

Authorized Agent and Import Assistance Services

Our Authorized Agent services offer you a strategic advantage, streamlining regulatory processes and ensuring compliance across borders. CliniExperts have a vast array of expertise in dealing with custom clearance, post market surveillance, pharmacovigilance, product performance, QMS, warehouse support and recall of products.

Authorized Agent And Import
Medical-icon

Medical Devices

Elevate your international market endeavors for Medical Devices.

drugs

Drugs

Boost your efforts to expand into international markets with authorized agents for Drugs.

IVD-icon

IVD

Enhance your global market initiatives with support and guidance of authorized agents

Biologicals-icon-violet

Biologicals

Unlock your global market opportunities effortlessly with assistance of agents for cosmetics.

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CliniExperts Research Logo Updated
Clinical trials

Clinical Trial Services

Looking for Clinical Trials? CliniExperts Research Services is your trusted Clinical Research Organization (CRO), committed to delivering top-tier clinical trials in strict alignment with ethical and regulatory standards. Our comprehensive services encompass clinical trial solutions, biometrics, regulatory approvals, and more. We boast extensive experience in conducting trials for drugs, medical devices, IVDs, biologicals, and vaccines for following services:

Clinical Trial Operations

Data Services/Biometrics

Clinical Trial Regulatory

Our Spectrum of services under various categories as follows—

Drugs

CliniExperts helps to conduct drug trials - New Drug, Fixed Dose Combinations, Investigational New Drug, Subsequent New drug and Phytopharmaceutical drug

Medical Devices & IVD's

CliniExperts assists in conducting Clinical investigation solutions for Medical Device and clinical performance evaluation of IVD

Biologicals

CliniExperts conduct Trials – Blood Products, DNA Products, Stem Cells and Cell based products, vaccines

Consumer Claims (Cosmetic and Food)

CliniExperts conduct studies- Efficacy Evaluation, Safety Evaluation, Sensory and Performance Evaluation, Product-Led Claims

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Global

Global Regulatory Services in EU, UK and USA

Empowering Your International Success

CliniExperts isn't confined by borders; our services extend beyond India to the EU, UK, and USA, covering Medical Devices, IVDs, and Drugs. At CliniExperts, we're your passport to seamless global market access. We simplify the path to product approval by tailoring country-specific regulatory strategies from the very inception of your product's development. Say goodbye to roadblocks, as we ensure a smooth journey to a successful product launch. Join us on the road to international success with confidence and expertise by your side.

Global Regulatory Excellence

Our Clients

eisai-pharma
galderma
win-medicare
medreich
daewoong
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Baxter
jw-holding
surtex
jeunesse-global
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fresenius
Leader-Biomedical
Ascensia-logo
unilever
Diversey
greencross
atomy
bunge
nignutra

Upcoming Regulations

Stay on top of industry-specific regulatory updates. Our in-depth analysis of upcoming regulations is your guide to maintaining compliance and success.

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CDSCO ICMR FSSAI
Regulatory Updates

Regulatory Update

March 12, 2024

Drug, Biologicals | CDSCO

Central Drugs Standard Control Organization (CDSCO) has issued a notice on 26.Feb.2024 stating that the stakeholders can submit applications for PSURs (Period Safety Update Reports) in relation to Marketing Authorization for New Drugs/Subsequent New Drugs(SND)/ Fixed Dose Combinations(FDC)/ Biologicals/Veterinary by...

READ MORE

Importer & Manufacturer

Regulatory Updates

Regulatory Update

March 8, 2024

CDSCO

A notice was published by the Central Drugs Standard Control Organization (CDSCO) Cosmetics Division of India on February 23, 2024, for all importers of cosmetics. It is urged that all the applicants who import cosmetics under COS-4A submit a statement...

READ MORE

Importer

Regulatory Updates

Regulatory Update

February 21, 2024

CDSCO

A notice was published by the Central Drugs Standard Control Organization (CDSCO) of India on February 12, 2024, for all stakeholders in the medical device industry. It is urged that all the stakeholders involved submit applications for Neutral Codes exclusively...

READ MORE

Manufacturer

Regulatory Updates

Regulatory Update

February 2, 2024

Drug | CDSCO

On January 16, 2024, the Central Drugs Standard Control Organisation (CDSCO) of India released a notification to all interested parties. The National Single Window System (NSWS) was created by the CDSCO to streamline corporate transactions and provide a single point...

READ MORE

Importer & Manufacturer

Regulatory Updates

Regulatory Update

January 12, 2024

Drug | CDSCO

On 28th December 2023, the Union Ministry of Health and Family Welfare implemented the Drugs (Amendment) Rules, 2023. Their objectives are to reinforce Good Manufacturing Practices (GMP) and establish requirements for premises, plant, and equipment in pharmaceutical products. The guidelines...

READ MORE

Importer & Manufacturer

Regulatory Updates

Regulatory Update

January 4, 2024

CDSCO

The Central Drugs Standard Control Organization (CDSCO) of India on January 01, 2024, published the notice for all the stakeholders. The CDSCO established National Single Window System (NSWS) to create a one-stop shop for all investor approvals and to facilitate...

READ MORE

Importer & Manufacturer

Regulatory Updates

Regulatory Update

January 4, 2024

CDSCO

The Central Drugs Standard Control Organisation (CDSCO) and the Indian Council of Medical Research (ICMR), working under the direction of NITI Aayog, seek to promote MedTech Mitra. This intends the development of accessible and reasonably priced domestic medical devices and...

READ MORE

Importer & Manufacturer

Regulatory Updates

Regulatory Update

December 5, 2023

Biologicals | CDSCO

On 10th November 2023, CDSCO issued a notification on the launch of the online system for Post-Approval Changes (PAC) with respect to Marketing Authorizations (MA) for human vaccines and anti-sera. With the introduction of the Online System of the SUGAM...

READ MORE

Importer & Manufacturer

Regulatory Updates

Regulatory Update

November 30, 2023

Food | FSSAI

On 17th November 2023, FSSAI issued a notification regarding the re-operationalization of the FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotic and Probiotic Food) Regulations, 2022 for 3 months from 1st October...

READ MORE

Importer & Manufacturer

Regulatory Updates

Regulatory Update

November 10, 2023

Food | FSSAI

As per the notification dated 12th October 2023, the FSSAI has directed all food safety enforcement authorities to ensure that products containing S-Adenosyl-L-Methionine (SAMe) as an ingredient alone or in combination with other ingredients are not available with FSSAI license...

READ MORE

Importer & Manufacturer

Certifications and Accreditations

With these certifications, we demonstrate our dedication to quality, safety, and customer satisfaction.

ISO-9001

ISO 9001

ISO-27001

ISO 27001

ISO New Logo

ISO 13485

Wholesale New Log

Wholesale

SOLUTIONS FOR DOMESTIC AND INTERNATIONAL MARKETS

We are regulatory solution provider catering to a vast array of services lines and products to simplify, familiarize and support our clients through every step of the regulatory process.

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CliniExperts in Media

Business Outlook
india today
forbes
industryoutlook
The_Economic_Times
Business-APAC
Express Pharma
CIOreview
silicon_india
Pharmabiz

September 5, 2023

CliniExperts – Most Promising Medical Device & Pharmaceutical Regulatory Consultant From Asia

CliniExperts is thrilled to announce our recognition by Business Outlook Magazine in their September edition. We are honored to be among the top 10 Regulatory and Pharma consultants in Asia, showcased on their cover story. Please read the full article...

February 2, 2023

Healthcare Budget 2023-24 gets its deserved due Insights from CliniExperts CEO

With several innovative measures that will transform the healthcare landscape, this budget is both path-breaking and path-setting for the industry. CliniExperts CEO Dr Ashwini Kumar decodes here the far-reaching implications of budgetary announcements for the healthcare sector.  

September 23, 2022

CliniExperts and vCare Denmark come together for inclusive and holistic Regulatory Solutions

CliniExperts and vCare Denmark come together for inclusive and holistic Regulatory Solutions    The power of partnership is greater than the capabilities of individual enterprise. Demonstrating this, CliniExperts and vCare Denmark have joined hands to co-create a holistic ecosystem of...

June 16, 2022

CliniExperts – The go-to-team for India’s healthcare regulatory affairs management – India Today

India Today published Cliniexperts, the Delhi-based consultancy as a gateway to India's healthcare regulatory affairs management. From Medical Devices to pharmaceuticals, biologicals, cosmetics, food, Nutraceuticals and vaccine product approvals, and much more, the company has provided end-to-end clinical and regulatory...

April 4, 2022

CliniExperts – The Multidisciplinary Regulatory Solution Provider – Forbes

Ms. Rashmi Verma, Chief Operating Officer at CliniExperts shared her idea of working at CliniExperts and how it is "The Multidisciplinary Regulatory Solution Provider" in the November Edition of "Forbes India" Magazine. She firmly believes that the regulatory scenario in...

February 2, 2022

Industry Outlook Magazine Recognised CliniExperts on its Cover Story, under the Top Ten Healthcare Regulatory Service Providers List-2022

  We are happy to announce that Industry Outlook Magazine January (2022) Edition listed CliniExperts Service Private Ltd. in top 10 Healthcare Regulatory Service Providers-2022 list. We steal the cover story of the month. CliniExperts is working in Streamlining the...

April 10, 2019

CliniExperts: India’s First Healthcare Regulatory Solutions Provider For Domestic And International Markets

Over the last two decades, the healthcare industry has seen a major consolidation of existing companies and emergence of startups. Many companies are moving from a traditional business approach to newer business verticals like medical devices, value-added wellness products, global...

August 20, 2018

Express Pharma: In the Quest of True Freedom

For more information, read here - http://www.expressbpd.com/pharma/cover-story/in-the-quest-of-true-freedom/403925/

July 13, 2016

A special feature – Companies invest in R&D to tap future opportunities- Chronicle Pharmabiz- August 7, 2014

All the legal compliances including pre-certifications, post-marketing surveillance queries, product recall request or any other request to be placed are taken care by the appointed authorized agent.

July 13, 2016

CliniExperts: Unmatched Regulatory Consultants in India

The year 2005 introduced a new era of product patent system in India. This helped science-based industries flourish exponentially resulting in an unprecedented demand for outsourced value-added services to pharmaceutical companies. However, this remarkable growth had triggered a need for...

Testimonials

The Brand That Promises To Turn, Your Business Around!

Randox Labortaroies

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

Nagaraj G P

Randox Labortaroies

Unity Enterprises

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

Mr. Faiyaz

Unity Enterprises

Atomy India Pvt ltd

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

Rajeev Kumar Rattawa

Atomy India Pvt ltd

Suretex Limited

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

Naavin Changchroenkul

Suretex Limited

Leader Biomedical and Surgicals India Pvt Ltd.

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

Jayakar Chandran

Leader Biomedical and Surgicals India Pvt Ltd.

Director – Proficon Medisol Pvt. Ltd.

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

Ajitesh Trehan

Director – Proficon Medisol Pvt. Ltd.

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

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

Radhakrishnan V.K

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

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

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

Sathya

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

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

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

Boddu Ganesh

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

Conybio Healthcare (India) Pvt. Ltd

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

Sunitha

Conybio Healthcare (India) Pvt. Ltd

Intercorp Biotech Limited

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

Yash Shrivastav

Intercorp Biotech Limited

C.E.O (Superchem Nutri Formulations)

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

R.L Goyal

C.E.O (Superchem Nutri Formulations)

Regulatory Affair Manager (Valentine Agro Pvt. Ltd.)

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

Pawan Shukla

Regulatory Affair Manager (Valentine Agro Pvt. Ltd.)

Blogs

February 14, 2024 / Drug

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 a drug license. The 1940 Drugs and Cosmetics...

February 14, 2024 / Drug

Key factors to keep in mind while getting approval for wholesale drug license registration

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

December 5, 2023 / Medical Device

CPCB Alert – Timely Annual Report to be Submitted by PIBOs to Avoid Penalties

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

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