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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.

Product Registration

Product registration helps you import & market your products in India through approvals from the Indian govt. regulatory authority, CDSCO, to tap market opportunities efficiently.

IVD/MD Performance Evaluation(PER)

The Central Drugs Standard Control Organization (CDSCO) is the regulatory body of India that provides clearances for Drugs, Medical Device, and IVDs.

Clinical Trials (Evaluation)

Clinical evaluation is a comprehensive assessment of a medical device's safety and performance based on clinical data collected by the legal manufacturer or gathered from independent sources.

Regulatory Approvals

Regulatory compliance processes and strategies are one of the pillars for Multinational organizations to attain their goals, as they must be cognizant of the rules of each country they operate within.

Legal Metrology

Legal Metrology is an act to establish and enforce standards that treat units of weights and measures, regulate trade and commerce in weights & measures of products

EPR (Extended Producer s Responsibility)

Extended Producer Responsibility (EPR) is a policy that is under the Ministry of Environment, Forest, and Climate Change (MoEFCC) in India, which is the primary body responsible for EPR implementation

License Holder

In order to legally market a product, compliance with Indian regulations is required. We can serve as Authorized Agents / Authorized representatives and Registration / License Holders.

Joint Venture/ Market Research

With our market research expert(s) and a network of 200+ distributors and 500+ Hospitals & Laboratories for various types of medical or clinical diagnostics, we provide information

Department for promotion of industry & internal trade

The Department for Promotion of Industry and Internal Trade (DPIIT) operates under Indias Ministry of Commerce and Industry, focusing on industrial sector growth.

Global Regulatory Business Consulting & Services

Utilizing our business consulting and management expertise, we offer a comprehensive array of services to IVD & Medical device companies.

GEM ( Government e Marketplace )

Launched on August 9, 2016, by Indias Ministry of Commerce and Industry, the Government e- Marketplace (GeM) revolutionizes public procurement. Our operations team offers a suite of services

Manufacturing Set Up / Product Development

Product Development and Manufacturing is pivotal in bridging healthcare gaps, empowering stakeholders to create solutions. Compliance with Indian regulations is essential for medical device manufacturing.

System Implementation

System implementation is critical for ensuring operational efficiency and quality standards in information systems. Leveraging our business operations management expertise,

Supply Chain Providers (Warehousing & Logistics)

Leveraging our expert consulting team in regulatory requirements for IVD & MD warehousing and logistics, we offer comprehensive solutions covering documentation, customs clearance

Accounting & Outsourcing

Utilizing our proficient operations team skilled in business account management, we deliver solutions encompassing Monthly Tax GST Filing, Yearly Audit Report, Invoicing, E-way Bill generation

More Services

Bio-State Consulting Pvt. Ltd. is the preferred regulatory consulting partner for companies of all sizes
seeking comprehensive end-to-end services for introducing innovative, safe, and effective Medical
Devices and IVDs.

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