International Regulatory Journey made Simple with End to End Compliance
We are a regulatory solutions provider serving the Medical Device, In-Vitro Diagnostic and drug. We are committed to simplify, familiarize, and support our clients through every step of the regulatory journey.
ISO 9001 & 27001 certified
Made in India, Made for the world
Trusted by over 20+ overseas clients
Experience + Expertise + Excellence
Ensuring smooth & seamless India entry
CliniExperts – The house of regulatory excellence
Post-pandemic, India has emerged as one of the fastest-growing healthcare markets with a 22% 2016-2022 CAGR. The growth is even and inclusive, spanning all verticals, be it drugs and pharmaceuticals, or vaccines and biologicals. Cumulative FDI inflows exceeded US$33 billion in March 2023. Strong political will and transformative reforms, coupled with a burgeoning economic middle class and lifestyle changes are proliferating the healthcare market and infrastructure to tier-II and tier-III cities of India. This translates into business opportunities of unprecedented scale.
Like scores of companies, if you are also pondering India entry with your healthcare product portfolio, CliniEpxerts is best-poised to offer you smooth and seamless, full-spectrum regulatory affairs services. With over a decade of committed services, CliniExperts’ current client-count stands at _ domestic and _ overseas customers. And it is growing fast, with good reasons.
From design to delivery, the CliniExperts regulatory partnership opens the doors to India’s booming healthcare industry for you.
Our standalone service features:
- To understand the Indian Industry and Regulatory landscape – the scenario, compliances and procedures.
- To identify the distribution network and associated challenges.
- To procure licenses and approvals.
- To study the Post Market Sustenance vis-à-vis the dynamic market and regulatory landscape.
Mission
To create a seamless healthcare regulatory ecosystem, and facilitate trouble-free India entry.
Vision
To be World’s most loved healthcare regulatory services provider.
Expanding Worldwide
With a team of 40+ seasoned experts well-versed in the latest regulatory landscapes of the USA, UK, and Europe, Company extends its services across borders. We cater to both international companies looking to penetrate the Indian market and Indian companies with aspirations of global expansion.
Our partnership with vCare Denmark has expanded our global reach, allowing us to serve clients across the world with this extensive outreach.
Our Happy Clients
Our Network Spans the Globe. Proudly serving for over 22 esteemed clients worldwide.
We collaborate with top-notch international companies that have a global reputation for their exceptional products, services, post-sales support, and customer satisfaction. They are dedicated to becoming an integral part of the Indian Healthcare Sector.
Team CliniExperts Helps its Clients
We commit to accompanying our clients throughout their entire journey in the global market.
Address all regulatory challenges that may arise in market entry.
Assist as Marketing Authorization Holder
Helps in various compliances
Assist in implementing QMS
CliniExperts Team
The CliniExperts team embodies a fusion of enthusiasm, expertise, and precision, consisting of capable, competent and qualified professionals.
Surender Sharma
Assistant Manager, Administration
Surender is the Administrative expert at CliniExperts. He is always on his toes to ensure CliniExperts works seamlessly at all times. Surender often is the person who remembers or can locate information from our records. He comes with over 15 years of industry experience. He has proven himself to be a good manager.
Surender spends his spare time honing his skills as a singer and dancer.
Yusra Usman
Manager - Regulatory Affairs
Yusra Usman comes with industry experience of over 10 years. She is the Food and Legal Metrology expert at CliniExperts and effectively handles the Regulatory Affairs for the same. She is process-oriented, and believes in following methods for even the smallest of concerns and ends up finding very quick solutions.
Yusra is keen on music and reading in her spare time.
Shipra Bisht
Senior Manager – Business Development
Shipra with her over 11 years of industry experience adds value to the client relations at CliniExperts. She has diligently been part of the teams that worked with many new clients. She has always shown her sharp business acumen and organized manner of working.
Shipra loves music, painting and movies.
Ashwani Yadav
Senior Executive – Regulatory Affairs (Medical Devices)
Ashwani is one of our most efficient team members. He is a key member of the Regulatory Affairs team that manages the Medical Devices sector. Always a team person, he can be relied upon for great solutions to all concerns.
Ashwani loves to try new recipes and listen to music.
Vijay Maurya
Senior Manager – Regulatory Affairs
Vijay Maurya, Senior Manager – Regulatory Affairs, has been a part of the Health Sector for over 12 years with a particularly deep understanding of the Drugs, Biologicals and Cosmetics. Vijay is known to be a very humble person.
He is an avid sportsperson.
Rajiv Kanwal
Senior Executive - Business Development
Rajiv Kanwal, Senior Executive - Business Development, has been a new addition to cliniExperts. He is responsible for Business Development.
Sonia Rana
Assistant Manager- Finance
She is capable of streamlining processes by using her methodical approach. Sonia excels at math, and her compassionate and composed demeanor endear her to those who surround her.
Brings 11 years of experience.
At The Helm
Dr Kumar is India’s recognised leader in healthcare regulatory affairs. A medical doctor and an alum of the prestigious AIIMS Delhi, Dr Kumar was deeply engaged with cutting-edge research while working with several frontline pharmaceuticals companies. In 2009, he established ClinIExperts with the mission of benchmarking healthcare regulatory affairs and compliance practices in India, and taking them to global levels of excellence. Today, the company is considered a go-to regulatory brand for Indian and overseas companies alike. His advice and opinion are often sought by a wide section of industry stakeholders.
Thus establishing CliniExperts, Dr Kumar went on to found CliniExperts Research Service Private Limited a decade ago, and took his deep passion for clinical research to the next level. Today, Dr Kumar and CliniExperts Research are synonymous with best practices and best outcomes in designing, implementing, and delivering world-class clinical research and trials.
In his leisure time, Dr Kumar loves to engage with budding entrepreneurs and professionals, and guide them on their academic and professional paths. A voracious subject-matter reader, he has a vast collection of industry-related material in his library.
Rashmi helms the tactical, operational, administration, people policy, accounts and payroll, and growth and expansion functions of CliniExperts. She also acts as the company-industry interface. Being a people person, Rashmi delights in meeting and interacting with employees and associates, and helping them excel at work and in life. Appropriately, she wears the trouble-shooter tag on her sleeves. Externally, Rashmi is fondly referred to as a friend, philosopher and guide.
An IT post-graduate and alum of the prestigious HBTI Kanpur, Rashmi is the force behind CliniExperts’ digital transformation drive, and aspires to achieve the digital-first stature shortly. Establishing a fully digitalised, humongous knowledge and information resource sharing critical industry updates, regulatory and compliance reforms, and approvals and licensing roadmaps is Rashmi’s cherished near-term digital goal.
Being passionate about technology and IT, Rashmi keeps herself constantly updated on the digital dynamics. Her other interests cooking and road trips.
Message from CEO
CliniExperts took flight in 2009, fuelled by a deep passion to comprehensively fulfil the Indian healthcare ecosystem’s regulatory and compliance requirements. My qualification as a doctor and a research background helped in this endeavour. From then till now, our team has emerged as India’s front-ranking regulatory service provider. Our hard work, single-minded dedication, and exemplary domain insights have helped us create regulatory archetypes that have become industry benchmarks.
To date, we have never had a case of an erroneous filing, which has led to a net-zero achievement in this context. Be it Indian manufacturers or overseas clients, we have fulfilled their regulatory mandates to their utmost satisfaction, creating fast, error-free, seamless, and end-to-end compliance experiences.
The India growth story in the healthcare sector is a critical reference point for all ambitious and visionary global players. For an ongoing, delightful regulatory compliance experience, you can count on us to evolve a trusted, lasting partnership. Please feel free to contact me 24/7 at [email protected]
Welcome to India, the gateway to Global Regulatory Excellence!
Dr Ashwini Kumar
CEO
We specialize in
Medical Devices
A guiding hand amidst regulatory intricacies for your medical devices.
In-Vitro Diagnostics
Navigating and aiding through the maze of regulations for IVDs.
Drugs
Regulatory Requirements and guidance for drugs.
Corporate Milestones
CliniExperts Services Pvt Ltd is the culmination of the vision of Dr Ashwini Kumar, MD (AIIMS). He envisioned being the World’s most loved healthcare regulatory services provider.
He chose to become the 'Go-To Regulatory Solutions Provider' for companies operating in various health sectors, including Medical Devices/diagnostic kits, Pharmaceuticals, Food/Nutraceuticals, Cosmetics, Biotech, and more. His vision was to empower the Global Health Sector and in 2009, it became a reality.
2013
By 2013, CliniExperts served 75 companies to get registered in India
2014
CIO Reviews featured us as one of 20 most promising Healthcare & Life Sciences Software companies in India.
2015
ISO 9001: 2008 Certification; over 200 clients; Entrepreneur of the Year Award for Dr Ashwini Kumar, CEO
2017
CliniExperts entered the India Market Division. We participated in the German Medical Device Trade Mission and received a record 280 approvals!
2018
CliniExperts set up its Singapore operations with a dedicated research center. Over 300 approvals obtained.
2019
A landmark year. Cosmoally App was launched, FoodSafetyMantra, A Blog on Food Regulatory Updates went live, Over 350 approvals obtained. The company breached the 500-clients threshold.
2020
CliniExperts played a key role in obtaining fast-track approvals for Covid-19 testing kits during the pandemic. This helped in timely detection of the virus and saving thousands of lives.
2023
CliniExperts establishes a full-fledged office in Bengaluru, empowered by dedicated professionals.
CliniExperts in Media
Testimonials
Cliniexperts are highly experienced in Indian regulatory, and the consultation provided is very quick and accurate. They are adaptable to the client needs and timely at the deliverables. We are very much satisfied with the services provided by Cliniexperts and would like to continue collaborating with them for our future research.
Ramya
Remedy
Working with CliniExperts has been an exceptional experience for our company KYOWA. Dr. Kumar and his knowledgeable team have a deep understanding of regulatory guidelines in India, coupled with their professionalism and expertise, which have greatly contributed to the success of KYOWA projects. The team at CliniExperts is dedicated, and responsive, and goes above and beyond to ensure that all aspects of regulatory compliance are met seamlessly. Their commitment to delivering top-notch services, backed by their years of industry experience, has been invaluable to our company KYOWA. We have completed numerous projects with CliniExperts, and their consistent performance and support have solidified our partnership. We highly recommend CliniExperts for its comprehensive regulatory solutions and unwavering commitment to excellence.
Read moreJaime C.
Division: Regulatory Affairs & Quality Assurance - Kyowa Hakko Bio Singapore Pte Ltd
Our India Services
CliniExperts Services Pvt. Ltd.
CliniExperts May assist you for:
- United Kingdom Market Services
- Europian Union Market Services