CliniExperts is your one stop solution for guiding you through the complex world of Healthcare Compliances, Regulations, and Clinical Trials.
For Importer
Form 40, 41
Biological Registration Certificate for Importers in India
For Importer
Form MD 14, MD 15
Import License for Medical Devices in India
For Importer
Form MD 14, MD 15
Import License For In-Vitro Diagnostic Kits in India
For Importer
Form Cos 1, Cos 2
Cosmetic Registration Certificate for Importers in India
For Importer
Form MD 16, MD 17
Test License to Import Medical Devices in India
For Importer
Form 8, 9, 10
Biological Import License in India
For Importer
Form V
BIS Certification for Foreign Manufacturers in India
For Importer
Authorized Agent Support in India
For Importer
Authorized Agent Support in India
For Importer
Authorized Agent Support in India
For Importer
Authorized Agent Support in India
For Manufacturer
Form CT 12, CT13, CT 14, CT 15, 29, 30
Test License to Manufacture Drug in India
For Manufacturer
Form 11, 12, CT-16 & CT-17
Test License to Import Drug in India
For Manufacturer
Form MD 3, MD 5
Permission to Manufacture Class B Medical Devices
For Manufacturer
Form MD 7, MD 9
Permission to Manufacture Class C & D Medical Devices
For Manufacturer
Form MD 4, MD 6
Retention of Loan Manufacturing License for Class A & B Medical Devices
For Manufacturer
Form Cos 5, Cos 6, Cos 8, Cos 9
Cosmetic Manufacturing License in India
For Manufacturer
Form I, V
CRS for Domestic Manufacturer for Electronic and IT Products
For Manufacturer
Form 24, 25
Permission to Conduct Clinical Performance Evaluation
For Manufacturer
Form B, Form C
FSSAI License for Food Supplements and Nutraceuticals
For Manufacturer
FSSAI Compliance - For Food Supplements & Nutraceuticals
For Manufacturer
Form A, B
Pre-Conception & Pre-Natal Diagnostic Techniques in India
For Manufacturer
Form 19, 20B, 21B
Wholesale Medical Device License in India
For Manufacturer
Form 19, 20B, 21B
Wholesale Drug License in India
For Manufacturer
Form 19, 20B, 21B
Wholesale Biological License in India
For Manufacturer
Form I , II
Non Specified Product / Ingredient Approval in India
For Manufacturer
Quality GxP Services For Pharmaceutical Manufacturers
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
Regulatory Requirements and guidance for Medical Devices
Importer
Guiding and assisting through the maze of Drug Regulations
Manufacturer
Navigating and aiding in the complex world of regulatory requirements.
Importer
Information and assistance on regulatory compliance for Food products.
Importer
Manufacturer
Guiding and assisting through the maze of regulations
Importer
Manufacturer
A guiding hand amidst regulatory intricacies for your cosmetic products.
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.
Elevate your international market endeavors for Medical Devices.
Boost your efforts to expand into international markets with authorized agents for Drugs.
Enhance your global market initiatives with support and guidance of authorized agents.
Unlock your global market opportunities effortlessly with assistance of agents for cosmetics.
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
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
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.
Stay on top of industry-specific regulatory updates. Our in-depth analysis of upcoming regulations is your guide to maintaining compliance and success.
Regulatory Update
May 7, 2025
Ministry of Mines releases an order on the goods or articles of refined zinc which should be corresponds to the specified Indian standard IS 209: 2024. The goods or articles fall under this Indian standard shall bear the standard mark...
Importer & Manufacturer
Regulatory Update
May 7, 2025
Ministry of Mines releases an order on the goods or articles of refined nickel which should be corresponds to the specified Indian standard IS 2782: 2023. The goods or articles fall under this Indian standard shall bear the standard mark...
Importer & Manufacturer
Regulatory Update
May 7, 2025
Ministry of Mines releases an order on the goods or articles of primary lead which should be corresponds to the specified Indian standard IS 27: 2023. The goods or articles fall under this Indian standard shall bear the standard mark...
Importer & Manufacturer
Regulatory Update
April 23, 2025
Medical Device | CDSCO
The Central Drugs & Standards Control Organisation (CDSCO) has enhanced its online Medical Devices system to enable automatic issuance of Market Standing Certificates (MSC) and Non‑Conviction Certificates (NCC) for licensed medical devices. Applications submitted under the previous workflow will be...
Importer & Manufacturer
Regulatory Update
April 18, 2025
Ayurvedic Drug, Drug, Phytopharmaceutical Drug | CDSCO
The Drugs Technical Advisory Board (DTAB) reviewed the 2nd assessment report by Prof. Kokate Committee on Fixed Dose Combinations (FDCs). The DTAB declared certain FDCs as rational with conditions and outlined a pathway for manufacturers to obtain product licenses. Manufacturers...
Manufacturer
Regulatory Update
April 18, 2025
Medical Device | CDSCO
The Medical Devices Online Portal now offers an automated process for generating Neutral Codes, replacing the previous manual system by the Central Licensing Authority. This update streamlines the export process for manufacturers holding a valid manufacturing license. Users can conveniently...
Regulatory Update
April 18, 2025
Ayurvedic Drug, Drug, Phytopharmaceutical Drug | CDSCO
The Central Drugs Standard Control Organization (CDSCO) has issued a directive to all State and Union Territory Drug Controllers to review and ensure compliance with the NDCT Rules 2019 under the Drugs & Cosmetics Act 1940. This follows concerns about...
Manufacturer
Regulatory Update
April 16, 2025
Medical Device, Diagonostic Kit | CDSCO
CDSCO has introduced an upgraded online workflow for the auto-generation of Market Standing Certificate (MSC) and Non-Conviction Certificate (NCC) for licensed medical devices. All applications submitted under the previous workflow will be automatically rejected, and stakeholders are required to resubmit...
Importer & Manufacturer
Regulatory Update
April 16, 2025
Medical Device | CDSCO
The CDSCO – Medical Devices Division has released an essential document addressing frequently asked questions on medical device regulations. This update covers critical aspects such as testing, licensing, labeling, and compliance requirements under IMDR-2017.
Manufacturer & Importer
Regulatory Update
April 16, 2025
Ayurvedic Drug, Drug, Phytopharmaceutical Drug | CDSCO
The Central Drugs Standard Control Organization (CDSCO) has released new guidelines for the transfer of drugs from Special Economic Zones (SEZ) to the Domestic Tariff Area (DTA). These guidelines aim to ensure that drugs meet quality, safety, and efficacy standards...
Importer & Manufacturer
With these certifications, we demonstrate our dedication to quality, safety, and customer satisfaction.
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.
July 26, 2024
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CliniExperts has been awarded the Certificate of Appreciation by the Central Board of Indirect Taxes and Customs (CBIC), Ministry of Finance, Government of India. This award was presented to CliniExperts for their prompt and substantial payment of Goods and Services...
September 5, 2023
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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
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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
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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
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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
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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
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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
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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
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For more information, read here - http://www.expressbpd.com/pharma/cover-story/in-the-quest-of-true-freedom/403925/
July 13, 2016
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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
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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...
The Brand That Promises To Turn, Your Business Around!
I want to extend my sincerest thanks for your diligent work and effort in submitting the claim approval application to the Regulatory Body. Your attention to detail and prompt communication have ensured that we remain on track and well informed throughout this submission process. We appreciate your continued support and professionalism. Thank you once again for your exceptional services.
Dr Nikhil Teli
Manager - Innovation, GCViDeal (A GCV Life Pvt. Ltd. Company)
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
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
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
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
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.
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.
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.
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.
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.
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
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
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)
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.)
April 21, 2025 / Default
This Article is All About Organic Food Labelling In India and Certification, and Import of Organic Food in India. Explained in Detail About What is Organic Food labelling? Summary Short...
March 26, 2025 / Default
Introduction Looking for Cosmetic Label Compliance India? Are you a cosmetic manufacturer or importer navigating the complex world of Indian regulations? Ensuring your product labels comply with the latest cosmetic...
January 15, 2025 / Medical Device
Summary Short Description Strict regulatory protocols govern clinical investigations for medical devices. Central to this process are forms MD-22 and MD-23. Form MD-22 is an application to Central Licencing Authority...
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