20 Years of Expertise in CDSCO Services and Medical Device Registration
At Rihim Pharma Consultancy, we understand the unique challenges and requirements of medical device registrations, and we have the knowledge, 2 decades of expertise, and key resources to guide you through the entire process. We take pride in our commitment to providing personalized, tailored services that meet the specific needs of our 500+ clients.
Complex Medical Device Regulations make registrations more Expensive
Despite a high-potential market, medical device registration in India can be a complex and time-consuming process for importers, traders, manufacturers and MNCs alike; presenting significant challenges for companies seeking to enter the Indian market. The regulatory landscape in India is constantly evolving, and we help you to simplify and smoothen your India regulatory strategy.
Registration of an Innovative/New Medical Device (MD 26)
Post approval changes
ISO 13485 from DCGI’s notified agencies »
Clinical Trial Approvals »
Import Test License (MD 16) »
In-Vitro Diagnostic Products/Kits »
What makes us different? Let’s count.
3-Layer Review of every Medical Device Application
One way we demonstrate this commitment is by having each project reviewed by three layers of internal experts. This ensures that every project is completed with the utmost attention to detail, reducing post-submission errors or queries, and maximising your chances of approval.
Our approval process exceeds the industry standard in terms of speed.
In addition, our efficient approvals are well known throughout the industry. We understand that time is money, and we work tirelessly to ensure that our clients’ products are approved as quickly as possible, without compromising on quality or regulatory compliance.
Dedicated Success Team
for each Project
We further demonstrate our commitment to providing exceptional service by dedicating a project management team to each client. This ensures that every project is completed on time and with the utmost attention to detail. Our project management team works closely with our clients to understand their unique needs and goals, and they provide regular updates on progress throughout the registration process.
Specialised for CDSCO
Finally, our strong followup with regulatory bodies are unrivalled in the industry. This helps us stay updated with every-day regulatory changes in requirements, address complicated queries and achieve timely approvals.
Let’s make a good team
So why choose Rihim for your medical device registration needs in CDSCO, India? We offer unparalleled expertise, personalized service, timely approvals, and a proven track record of success with 8500+ approvals from CDSCO. Our team is dedicated to helping you achieve your goals and ensuring that your products reach the Indian market as quickly and smoothly as possible, in compliance with all the applicable regulations.
To learn more about our services and how we can help you with your medical device registration needs, please contact us today. We look forward to working with you!
About our Founder & CEO
Meet Mr. Nilesh Thosani, the founder of Rihim Pharma Consultancy. With over 20 years of experience in the pharma, medical device, vaccines, biotechnology and related industries, he has established himself as one of the foremost experts in regulatory affairs in India.
Mr. Thosani is a trailblazer in the industry, having established the first regulatory consulting company in India to work with the Central Drugs Standard Control Organization (CDSCO). He has played a key role in shaping the regulatory landscape in India and has helped numerous companies successfully navigate the complex and ever-changing regulatory requirements.
Over the years, Mr. Thosani has earned numerous accolades for his exceptional work, including awards from companies such as Akzo Nobel for being the best service provider. His commitment to providing win-win solutions for all stakeholders has earned him a reputation as a trusted and reliable partner in the industry.
In addition to his extensive industry experience, Mr. Thosani has developed positive relationships with regulatory authorities and the Ministry of Health in India. These relationships, combined with his deep knowledge of the regulatory landscape, have made him an invaluable resource for companies seeking to enter the Indian market.
As a go-getter and inspiring leader, Mr. Thosani is dedicated to providing exceptional service to his clients and helping them achieve their goals. He leads by example, instilling a culture of excellence and accountability throughout the organization. His passion for the industry and commitment to success make him a true asset to the Rihim Pharma Consultancy team.