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
Form 40, 41
BIOLOGICAL
Biological Registration Certificate for Importers in India
For Importer
Form MD 14, MD 15
MEDICAL DEVICE
Import License for Medical Devices in India
For Importer
Form MD 14, MD 15
IN-VITRO DIAGNOSTIC
Import License For In-Vitro Diagnostic Kits in India
For Importer
Form Cos 1, Cos 2
COSMETIC
Cosmetic Registration Certificate for Importers in India
For Importer
Form MD 16, MD 17
MEDICAL DEVICE
Test License to Import Medical Devices in India
For Importer
Form 8, 9, 10
BIOLOGICAL
Biological Import License in India
For Importer
Form V
BIS CERTIFICATION
BIS Certification for Foreign Manufacturers in India
For Importer
MEDICAL DEVICE
Authorized Agent Support in India
For Importer
IN-VITRO DIAGNOSTIC
Authorized Agent Support in India
For Importer
DRUG
Authorized Agent Support in India
For Importer
BIOLOGICAL
Authorized Agent Support in India
For Manufacturer
Form CT 12, CT13, CT 14, CT 15, 29, 30
DRUG
Test License to Manufacture Drug in India
For Manufacturer
Form 11, 12, CT-16 & CT-17
DRUG
Test License to Import Drug in India
For Manufacturer
Form MD 3, MD 5
MEDICAL DEVICE
Permission to Manufacture Class B Medical Devices
For Manufacturer
Form MD 7, MD 9
MEDICAL DEVICE
Permission to Manufacture Class C & D Medical Devices
For Manufacturer
Form MD 4, MD 6
MEDICAL DEVICE
Retention of Loan Manufacturing License for Class A & B Medical Devices
For Manufacturer
Form Cos 5, Cos 6, Cos 8, Cos 9
COSMETIC
Cosmetic Manufacturing License in India
For Manufacturer
Form I, V
MEDICAL DEVICE
CRS for Domestic Manufacturer for Electronic and IT Products
For Manufacturer
Form 24, 25
DRUG
Permission to Conduct Clinical Performance Evaluation
For Manufacturer
Form B, Form C
FOOD
FSSAI License for Food Supplements and Nutraceuticals
For Manufacturer
FOOD
FSSAI Compliance - For Food Supplements & Nutraceuticals
For Manufacturer
Form A, B
MEDICAL DEVICE
Pre-Conception & Pre-Natal Diagnostic Techniques in India
For Manufacturer
Form 19, 20B, 21B
MEDICAL DEVICE
Wholesale Medical Device License in India
For Manufacturer
Form 19, 20B, 21B
DRUG
Wholesale Drug License in India
For Manufacturer
Form 19, 20B, 21B
BIOLOGICAL
Wholesale Biological License in India
For Manufacturer
Form I , II
FUNCTIONAL FOOD
Non Specified Product / Ingredient Approval in India
For Manufacturer
PHARMACEUTICAL
Quality GxP Services For Pharmaceutical Manufacturers
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.
Medical Devices
Elevate your international market endeavors for Medical Devices.
Drugs
Boost your efforts to expand into international markets with authorized agents for Drugs.
IVD
Enhance your global market initiatives with support and guidance of authorized agents.
Biologicals
Unlock your global market opportunities effortlessly with assistance of agents for cosmetics.
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
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.
Our Clients
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.
Regulatory Update
December 18, 2024
Functional Food, Food | FSSAI
The notification publishes the Food Safety and Standards (Amendment) Rules, 2024, which amend the Food Safety and Standards Rules, 2011. The amendments were made after considering public objections and suggestions on a draft published earlier. The notification states that the...
Importer & Manufacturer
Regulatory Update
December 18, 2024
Functional Food, Food | FSSAI
The FSSAI advisory notifies enforcement authorities about an accredited laboratory for testing prohibited substances in “Food for Sportsperson.” This laboratory, accredited by NABL, can now be utilized to test for substances declared by the World Anti-Doping Agency (WADA). The advisory...
Importer & Manufacturer
Regulatory Update
December 18, 2024
Functional Food, Food | FSSAI
The Food Safety and Standards Authority of India (FSSAI) has reclassified Packaged Drinking Water and Mineral Water as “High Risk Food Categories.” This new categorization mandates stricter regulatory oversight, including more frequent inspections and mandatory annual audits for manufacturers. The...
Manufacturer & Importer
Regulatory Update
November 14, 2024
Functional Food, Food | FSSAI
FSSAI has issued a notification amending the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. The amendment introduces revised standards for Mozzarella Cheese, categorizing it based on fat content. It also establishes microbiological standards for Neera,...
Importer & Manufacturer
Regulatory Update
November 14, 2024
Functional Food, Food | FSSAI
FSSAI has issued a notification amending the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011. The amendment primarily focuses on modifying provisions related to the sale of infant nutrition, condensed milk, skimmed milk powder, packaged drinking water, multi-source...
Importer & Manufacturer
Regulatory Update
November 14, 2024
Medical Device | CDSCO
This form is designed to capture information on adverse events related to medical devices in India. It is intended to be used by manufacturers, importers, distributors, and healthcare professionals to report incidents and potential device-related issues. The collected data will...
Importer & Manufacturer
Regulatory Update
November 14, 2024
Functional Food, Food | FSSAI
FSSAI has amended the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011, to further strengthen food safety standards in India. The amendment introduces stricter limits for contaminants like Ochratoxin A and Deoxynivalenol in certain food products. Additionally, it...
Manufacturer & Importer
Regulatory Update
October 16, 2024
Ayurvedic Drug, Drug, Biologicals, Phytopharmaceutical Drug | CDSCO
The Central Drugs Standard Control Organization (CDSCO) has made online submission mandatory for applications seeking New Drug permission of Vaccines/ Drugs for Bulk (API) in Form-45A/46A and finished formulation in Form-45/46 and Field Trial Permission for Veterinary purpose only. The...
Importer & Manufacturer
Regulatory Update
September 11, 2024
Cosmetic | CDSCO
The CDSCO has restricted the number of products per online application on the SUGAM portal for cosmetics registration and import to a maximum of 50 effective August 16. Multiple applications can be made to register more products. This change aims...
Importer & Manufacturer
Regulatory Update
September 4, 2024
Ayurvedic Drug, Drug, Phytopharmaceutical Drug | CDSCO
Drug Controller General (India) Circular The DCGI has issued a circular regarding the implementation of revised Schedule M and WHO Technical Report Series (TRS) guidelines. All vaccine and sterile product manufacturers are requested to comply with the requirements outlined in...
Manufacturer
Certifications and Accreditations
With these certifications, we demonstrate our dedication to quality, safety, and customer satisfaction.
ISO 9001
ISO 27001
ISO 13485
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.
CliniExperts in Media
July 26, 2024
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CBIC honours CliniExperts for Outstanding GST Compliance in FY 2023-24
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 – 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
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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
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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
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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
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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
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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...
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April 10, 2019
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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
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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/
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July 13, 2016
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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
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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!
Manager - Innovation, GCViDeal (A GCV Life Pvt. Ltd. Company)
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
Regulatory Affair Manager (Valentine Agro Pvt. Ltd.)
Blogs
November 4, 2024 / Samd
Regulatory Challenges of SaMD: Navigating Global Standards and Compliance
Navigating Software as a Medical Device regulation involves addressing varying global standards, including risk-based classifications.
November 4, 2024 / Samd
The Future of SaMD: Emerging Trends and Innovations
The future of Software as a Medical Device will see breakthroughs in Artificial Intelligence-based diagnostics, personalised treatments, and remote monitoring.
November 4, 2024 / Samd
Understanding SaMD: What Makes Software a Medical Device?
Software as a Medical Device refers to software applications designed for medical purposes, such as diagnosis, treatment, or monitoring, without being part of a physical device.