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.

Timeline of Company History

2009

  • CliniExperts founded (2009), is a brain child of Dr. Ashwini Kumar who nurtured a vision to use his extensive knowledge of the Pharmaceutical industry and passion for innovation to aid society in getting access to affordable life-saving drugs. The company branched out with time covering all primary areas in the pharmaceutical field.

2012

  • Launched our upgraded website

2013

  • Celebrated 5 years with over 75 satisfied clients

2014

  • Moved to Janakpuri office
  • CliniExperts listed in 20 Most Promising Healthcare and Life sciences Software Companies in a list compiled by CIO Reviews

2015

  • The CliniExperts family expands while reaching and crossing the milestone of serving over 200 clients
  • Achieved ISO 9001:2008 certification
  • Dr. Ashwini (CliniExperts Founder & Director) received the Entrepreneur of the year-2015 award from Silicon India

2016

  • Launched our upgraded website

TESTIMONIALS

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

  • Connexicon Medical
  • Diacare Solutions
  • Nutech Mediworld
  • Glectore
  • DS Group
  • Tergene
  • Duraent Biologicals
  • Sunways
  • Eucare
  • DABUR
  • EISAI PHARMA
  • GALDERMA
  • LEGRAND
  • WOCKHARD
  • MERZ ASIA
  • AMWAY
  • MODI MUNDI
  • KAPPA BIOSCIENCES
  • CUXSON GERRARD
  • FOREVER LIVING
  • KHANDELWAL LABS
  • Mc Cain
  • MEDREICH
  • Britvic
  • ZIPLINE
  • SHAKLEE
  • VALENTINE/ NATUREX
  • AEON FORMULATIONS
  • ATHENA DRUG DELIVERY
  • IPCA Laboratories
  • MEDIZONE AESTHETICS
  • TABLETS INDIA
  • SHIELD HEALTHCARE
  • RP TELEBUY
  • NOVOTECH
  • MARYA DAY AGRO FOOD
  • CONYBIOHEALTH CARE
  • CREATIVE HEALTHCARE
  • IPROCESS
  • INTERCORP BIOTECH
  • LAMBDA/ GETZ
  • SUNGLOW
  • JOHNSON HEALTHCARE
  • Tarius
  • TROPHIC WELLNESS
  • Curatio
  • Datar Genetics
  • Daewoong Pharma
  • Generex
  • George Institue
  • Apeejay Stya
  • Orbit Lifesciences
  • R R Salon
  • RPG Lifesciences
  • Netsurf
  • Art Life
  • Merisant
  • Cell Research Corp
  • Sekisui Chemicals
  • Fuji Chemicals
  • Finlinea
  • Omni Active
  • Rich Feel
Connexicon Medical
Diacare Solutions
Nutech Mediworld
Glectore
DS Group
Tergene
Duraent Biologicals
Sunways
Eucare
DABUR
EISAI PHARMA
GALDERMA
LEGRAND
WOCKHARD
MERZ ASIA
AMWAY
MODI MUNDI
KAPPA BIOSCIENCES
CUXSON GERRARD
FOREVER LIVING
KHANDELWAL LABS
Mc Cain
MEDREICH
Britvic
ZIPLINE
SHAKLEE
VALENTINE/ NATUREX
AEON FORMULATIONS
ATHENA DRUG DELIVERY
IPCA Laboratories
MEDIZONE AESTHETICS
TABLETS INDIA
SHIELD HEALTHCARE
RP TELEBUY
NOVOTECH
MARYA DAY AGRO FOOD
CONYBIOHEALTH CARE
CREATIVE HEALTHCARE
IPROCESS
INTERCORP BIOTECH
LAMBDA/ GETZ
SUNGLOW
JOHNSON HEALTHCARE
Tarius
TROPHIC WELLNESS
Curatio
Datar Genetics
Daewoong Pharma
Generex
George Institue
Apeejay Stya
Orbit Lifesciences
R R Salon
RPG Lifesciences
Netsurf
Art Life
Merisant
Cell Research Corp
Sekisui Chemicals
Fuji Chemicals
Finlinea
Omni Active
Rich Feel

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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