End-to-end regulatory
solutions
for domestic and international markets

We are regulatory solutions 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

End-to-End Regulatory Solutions

CliniExperts – Scientific, Systematic and Synergistic

The founding principle of CliniExperts is to facilitate the entry of quality products in the market by helping our clients ease through the various regulatory aspects they face. We act as the bridge that joins research and the market by offering quality services to our clients that will help them gain a firm footing in the market.

CliniExperts work towards the mission of paving the way for a safer, healthier society through facilitating the availability of quality products in the market.

CliniExperts is India’s leading regulatory solutions provider recognized for its meritocracy, stringent QA and QC standards, up-to-the-minute knowledge base, professionalism and unquestionable ethics. It offers end-to-end regulatory solutions to pharma, food, cosmetic, medical devices, nutraceuticals, biological & vaccines industries.

CliniExperts CEO

Dr. Ashwini KumarDr. Ashwini Kumar, MD (AIIMS) has a total commitment to medical research and its significance to the world of tomorrow. And more importantly, he is committed to the need for absolute perfection and ethical correctness. Indeed, one of his guiding principles is: “If it’s not right, it has no value; if research and testing are not totally credible, the results are worthless to the pharma industry and society in general.”

Having gained MBBS degree from Kasturba Medical College, Mangalore in 2003, Dr. Kumar went on to study at the prestigious All India Institute of Medical Sciences (AIIMS), graduating MD in Molecular Pharmacology in 2007. At AIIMS, Dr. Kumar worked on molecular cloning, expression, purification and structure-based rational design of inhibitors against human Cyclooxygenase-2.

He began his career in medical research while at the R&D unit of AIIMS, working on various projects in association with many global pharma companies and CROs, where he focused on the investigational site management aspects of clinical trials.

After Post Graduation, Dr. Kumar moved into the industry, joining Max Neeman International, a leading pharma and biotechnology Contract Research Organization, as a medical monitor, supervising regulatory affairs, quality assurance and training. His work involved frequent liaison with the health regulatory authority at Central Drug Standard Control Organization (FDA Bhavan) in order to solve technical queries and to expedite regulatory approval process.

In May 2009, Dr. Kumar established CliniExperts Services Pvt. Ltd, to provide outsource facilities covering regulatory affairs services, and its support services to international pharma companies, biotech industry, medical device / diagnostic kit companies, food /nutraceutical companies, cosmetic industry and CROs.

Dr. Kumar is a quality-focused professional, who believes that the focus of his company’s mission should be the provision of efficient and quality driven regulatory affair services to all clients.

CliniExperts COO

Rashmi VermaRashmi Verma is our Chief Operating Officer at CliniExperts and has dedicated the last 16 years to make remarkable contributions to the industry with her software engineering expertise. Her fields of expertise lie in big data analytics, software development, delivering timely executions and managing teams, which have helped our organization grow substantially with her spearheading several operations.

Rashmi is a notable alumni of H.B.T.I., Kanpur, where she pursued her Bachelor’s degree in Technology (Computer Science and Engineering) from 2000-2004. At CliniExperts, she designs and implements business strategies, processes, and plans for the company and oversees its day-to-day operations. Her role also includes building and maintaining positive relationships with company customers and managing digital marketing efforts by staying up-to-date on technologies that could benefit company operations and expansion. Our chief operations officer’s role involves establishing policies and procedures for the company’s I.T., business, development, regulatory operations, finance, and administrative departments.

In her time with CliniExperts since 2014, she has proven herself a significant trailblazer with her extraordinary work ethic, business strategies, and warm demeanor. Rashmi also manages all the digital assets of the website, the blog Food Safety Mantra, our research website and CliniExperts’ mobile app. Most importantly, all these ideas are her brainchild, including handling the digital front of the organization. Her vibrant and energetic personality takes challenges head-on with grace, while achieving the organization’s best results through innovative techniques and an entrepreneurial vision by directing the future steps of CliniExperts.

Timeline of Company History

2009

Founded in 2009 and based in New Delhi, CliniExperts is India’s leading regulatory solutions provider to various industries such as pharma, food, cosmetics, medical devices, etc. We are the brainchild of Dr. Ashwini Kumar, MD (AIIMS), who nurtured his vision to aid the society in getting access to affordable life-saving drugs.

2012

A milestone year, in 2012, we launched the upgraded website and also achieved the mark of getting our first 50+ clients.

2013

This year, we further strengthened our mission. We completed a successful five-year run with over 75 satisfied and happy clients.

2014

A yet another triumphant year for us. In 2014, we got featured in a compilation of 20 Most Promising Healthcare and Life sciences Software Companies by CIO Reviews.

2015

Not only did we reach over 200 clients in 2015, but also achieved ISO 9001: 2008 certification.
Dr. Ashwini Kumar, our founder & director, received the Entrepreneur of the year-2015 award from Silicon India. 2015 was indeed special for us.

2016

In 2016, we revamped our website to align with the business goals. The upgraded website provided a seamless experience to our clients.

2017

2017 marked our entry to the India Market Division. We also participated in the German Medical Device Trade Mission and received over 280 approvals.

2018

2018 was a stupendous year of growth for us. CliniExperts set up an office in Singapore, and our research segment was established. We also received 300+ approvals.

2019

We extended our growth spree to 2019 as well. We launched our Cosmoally app, initiated a blog page for food regulatory updates – FoodSafetyMantra, and also received over 350 approvals. What’s more, our clientele also crossed the 500-mark.

2020

In our quest to serve society reeling for the global pandemic, in 2020, we successfully registered COVID-19 (coronavirus detection) kits.

TESTIMONIALS

Radhakrishnan V.K 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.

Sathya 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.

Boddu Ganesh 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.

Sunitha 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.

Yash Shrivastav 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.

R.L Goyal 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.

Pawan Shukla 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.

Our Clients

  • EISAI PHARMA
  • GALDERMA
  • FOREVER LIVING
  • MEDREICH
  • Daewoong Pharma
  • Raymond Consumer Care Pvt ltd
  • Dr Recella
  • Randox Laboratories
  • Lion Corporation
  • Gainwell Industries
  • MEBO International
  • TheHut.com Ltd
  • Etude House Team (Innisfree Cosmetics India Pvt. Ltd.)
  • Morepen Laboratories Ltd.
  • Altona Diagnostics India Private Limited
  • Heager India Pvt Ltd
  • Healthium Medtech Pvt. Ltd.
  • Earth Corporation
  • Merz Asia
  • Baxter
  • JW Holding
  • Suretex Prohylactics (India) Private Limited
  • jeunesse global
  • Omron
  • fresenius medical care
  • JW Holding
  • Leader-Biomedical
  • Ascensia-logo
  • Unifield
  • Diversey
  • greencross
  • atomy
  • bunge
  • signutra
  • win-medicare
Raymond Consumer Care Pvt ltd
Dr Recella
Randox Laboratories
Lion Corporation
Gainwell Industries
MEBO International
TheHut.com Ltd
Etude House Team (Innisfree Cosmetics India Pvt. Ltd.)
Morepen Laboratories Ltd.
Altona Diagnostics India Private Limited
Heager India Pvt Ltd
Healthium Medtech Pvt. Ltd.
Earth Corporation
Merz Asia
Baxter
EISAI PHARMA
GALDERMA
FOREVER LIVING
MEDREICH
Daewoong Pharma
JW Holding
Suretex Prohylactics (India) Private Limited
jeunesse global
Omron
fresenius medical care
JW Holding
Leader-Biomedical
Ascensia-logo
Unifield
Diversey
greencross
atomy
bunge
signutra
win-medicare

At CliniExperts, we've got the answer to every query, the solution to every problem and the expertise to meet every regulatory barrier that you face. With an experienced team to guide you throughout the regulatory process, your journey becomes convenient and result-oriented. Our guidance will help you take decisive action based on firm strategies in order to achieve sustainable results.

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