• BIO STATE CONSULTING,
    YOUR PARTNER FOR REGULATORY
    COMPLIANCE IN INDIA
    Serving the In-Vitro Diagnostics IVD/MD Industry since 2012
  • REGULATORY APPROVALS
    & CERTIFICATION
    CDSCO/Indian FDA Approvals/Regulatory Affairs partner, 100% guaranteed product approval
  • LEGAL METROLOGY
    End To End Services
  • EPR(Extended Producer Responsibility )For Plastic Waste
    EPR Certification for Plastic Waste
  • DPIIT ( Department for Promotion of Industry and Internal Trade )
    DPIIT is responsible for the overall industrial policy.
  • LICENSE HOLDING / AUTHORISED REPRESENTATIVE
    Your Virtual office in India
  • JOINT VENTURE/MARKET RESEARCH/MANUFACTURING
    FACILITY SETUP
    Helps you in setting up new facility to enter in Indian Market
  • IVD/MD PERFORMANCE
    EVALUATION REPORTS
    As required by IVD/MD CDSCO Regulation
  • PROVIDE YOU SALES
    & MARKETING TEAM/ENABLING
    DISTRIBUTION NETWORK
    Helps in providing you the best team positioning your product at right time at right place.
  • OFFICE SET-UP
    / ACCOUNTING & OUTSOURCING
    We provide End to End Solutions.
  • WAREHOUSING & LOGISTICS
    One stop solution from Logistic to Dispatch
  • GeM (Goverment e -Marketplace )
    We help you to register your product on GeM portal

WELCOME TO BIOSTATE CONSULTING

BioState Consulting is a full-service regulatory and product development consulting firm for IVDs, and medical devices. BioState Consulting has become the go-to consulting partner for companies large and small seeking to bring innovative, safe and effective products to Indian market.

It is the experience that allowed us to provide an unparalleled “approach” on how best to navigate your new product from discovery through testing, nonclinical work, clinical trials, regulatory approvals, and ultimately arrive at market in the most efficient manner.

BioState Consulting hold the promise of a better future for everyone in the IVD Industry & medical devices.

We view each challenge as an opportunity to leverage our Industry and Agency experience in order to facilitate a better outcome for our client.

KNOW MORE

“We provide the best knowledge of the Laws & Regulations pertaining to product approval, development, manufacturing, commercialisation, enabling distribution network, market study. Our focus is providing speedy approvals to the clients in a more efficient & cost-effective way so that the client can achieve their goal in a successful way.”

INDUSTRY WE SERVE

Our Regulatory consulting and operations team are experts in regulatory requirements. Working on a global scale, we help the majority of the world’s companies stay one step ahead of regulatory changes, and optimize their end-to-end regulatory activities.

IVD (In-Vitro Diagnostics )

MEDICAL DEVICES

FOUNDED
IN
2012.

Leading provider of regulatory compliance products and services

11+

YEARS OF EXPERIENCE

100%

CLIENT FOCUSED

100%

RESULTS GUARANTEED

OUR FOUNDER

Nitin Gupta is post graduate from AAIDU in the field of Bioinformatics .

He has extensive corporate experience of working with renowned organizations like Tosoh India Pvt. Ltd , SD Biosensor Healthcare Pvt. Ltd. , Alere Medical India Pvt. Ltd. & having wide experience in MD /IVD field .

In Jan. 2012 , Nitin Gupta started his own venture ” Bio State Consulting “to provide regulatory and product development consulting services for Medical Devices and IVD’s in India and abroad

Now company has 250+ Domestic Clients and 90+ International Clients

Now the company is associated with 250+ Domestic Clients and 90+ International Clients

 

 

 

 

SERVICES

Biostate consultant provides the knowledge & experience in the healthcare from Registration of Medical devices to Market assessment & distribution set up. We provide our help in the licensing work with the CDSCO (Regulatory Authority India) so as to solve the technical queries.

Strategy & Implementation

Bio-State Consulting assists you in utilizing compliance requirements as a business value & transform them into success. From Initial design & development to management of medical devices & In Vitro diagnostics, our services help clients to efficiently establish, implement & maintain all relevant framework processes & documents.

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