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.
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.
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.
Warehousing & Logistics
Bio state consulting provides warehousing logistics services for our international as well as domestic clients . It includes custom clearance , transportation, storage & dispatch etc. One stop solution from logistic to dispatch.
Accounting & Outsourcing
Bio state consulting provides you accounting outsourcing for international clients who have subsidary office in India . Monthly GST Filing, Yearly Audit Report , Invoicing and E-way Bill generation and all compliance as per Indian company act .
GeM (Government e-Marketplace)
The Government e-Marketplace is an online platform for public procurement in India. The initiative was launched on August 9, 2016, by the Ministry of Commerce and Industry, Government of India with the objective to create an open and transparent procurement platform for government buyers. GeM (Government e-Marketplace) Registration, Vendor Assessment, OEM Panel, Brand Approval, Profile […]
Joint Venture / Market Research
Bio state Consulting has a network of 200+ distributor and 500+ Hospitals and Laboratories. With the help of this network we provide information of Indian market for various type of device used to diagnose disease or medical condition . These reports can help with communication , risk prevention , reputation and decision making for management […]
Legal Metrology
“Legal Metrology means that part of metrology which treats units of weighment and measurement, in relation to the mandatory technical and legal requirements”. Certificates of Legal Metrology is issued under Ministry of Consumer Affairs, Food & Public Distribution. Various types of license are issued under Legal Metrology. BioState Serves Businesses across the entire Legal Metrology […]
IVD/MD PERFORMANCE EVALUATION REPORTS
As per CDSCO Guidelines Bio State Consulting provides IVD/MD Evaluation Performance Report (PER) HIV, HBV, HCV, Blood Grouping reagent, Cancer, Tuberculosis, Malaria, Dengue, Chikungunia, Syphlis, Typhoid, Influenza, ToRCH (Toxoplasma gondii, Rubella virus, Cytomegalovirus, Herpes simplex virus) Chlamydia Pneumonia, Methicilline-Resistant Staphylococcus Aureus, Entero virus, Marker for congenital disorder e.g. Screen test for Down’s Syndrome Sexually transmitted […]
DPIIT (Department for Promotion of Industry and Internal Trade)
The Department for Promotion of Industry and Internal Trade (DPIIT) is a central government department under the Ministry of Commerce and Industry in India. It is responsible for formulation and implementation of promotional and developmental measures for growth of the industrial sector, keeping in view the national priorities and socio-economic objectives. While individual administrative […]
EPR(Extended Producer Responsibility)
EPR (Extended Producers Responsibility) regime is under implementation in plastic waste management rules 2016, according to which it is the responsibility of producers, importers and brand owners to ensure processing of their plastic packaging waste through recycling, re-use or end of life disposal. The EPR concept was first introduced in India in the early 2000s […]
Global Regulatory Business Consulting & Services
We at BioState specializes in providing regulatory compliance, market intelligence, quality assurance & clinical consulting services to global medical device & IVD manufacturers or suppliers want to market our launch their product in India.
Manufacturing Set Up/Product Development & Commercialisation
BioState assists its clients in establishing infrastructure by building competencies for the stakeholders to develop and provide products and solutions facilitating the industry and nation at large in bridging the healthcare gaps.
License Holder
In order to legally sell& market your product in India you need to be compliant to Indian regulations & govt defined systems. We at Biostate will be responsible for pre-certification & post market surveillance inquiries. We can serve as an Authorized Agent/Registration Holder
Products Registration for Wholesale & Manufacturing License
We provide effective, efficient, integrate science & regulations to overcome the product commercialization. So, we at Biostate provide help in efficient & effective product registration services. And we help you import
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