Bio-State Consulting
Our vast experience of 11 years in Medical Devices and IVD gives us an edge to assist in the complete lifecycle of the product right from discovery through testing, nonclinical work, clinical investigation, regulatory approvals, and ultimately go to market in the most efficient manner.
Bio State Consulting Pvt. Ltd. is providing regulatory and product development consulting services for Medical Devices and IVD’s in India.
We are the preferred consulting partner for all scale of companies seeking to introduce innovative, safe and effective products .
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WE OFFER DEPENDABLE REGULATORY CONSULTING FOR ALL THE ASPECTS OF MEDICAL DEVICES. OUR TEAM CONDUCT REGISTRATIONS OF MEDICAL DEVICES. WE HAVE OVER 12 YEARS OF EXPERIENCE IN THE CONSULTING BUSINESS. WE ALSO HELP IN PROVIDING THE PRODUCT REGISTRATION WITH THE INDIAN FDA (CDSCO).
The Central Drugs Standard Control Organisation is the regulatory body of India that provides clearances of Drugs, Medical Device, and IVDs & allows manufacturers to understand the regulatory of medical device & IVDs.
We at Biostate help in providing the Registration Certification and other relevant licenses such as Import License (MD 14), Test License (MD 16) along with the renewal which helps in successfully import of the products into India with registration. We as an authorized agent provide high-quality & professional services & develop long term relationships. Our overall experience includes NIB evaluation of test kits, clinical trial approvals, product registrations, marketing authorizations, and import authorizations. We guarantee fast & comprehensive advice on regulatory challenges.
MISSION
” To provide End to End solutions For regulatory services in the field of Medical Devices & IVD business right from Market Entry to Success . “
VISION
” To become the most preferred brand for all regulatory services in the field of MD & IVD In India . “
