Zichor Life Tech

about us

Zichor Life Tech Pvt. Ltd. was established in 2023 and became operational in August 2025. Founded by a team of three experienced doctors (Dr. Sathya, Dr. Chaitanya and Dr. Swetha). Built with a strong vision of saving lives through advanced medical solutions. Specifically designed to support surgeons, incorporating their practical expertise and clinical insights. Focused on delivering high-quality, reliable, and effective surgical products.

Department Contacts

MEET THE TEAM

Dr. Chaithanya

Managing Director

Dr. Sathyanarayana

Director & CEO

Dr. Swetha

Director & CFO

Rashmi Nair

Chief International Business Officer

S M Narayan

Head of HR

Jayanth Birari

Head of Operation

Raghvendra

Head of Quality

Arun Kumar

Head of Accounts

Rupesh Shimpi

Graphic Designer

Zichor Life Tech Pvt. Ltd. operates on a 3,50,000 sq. ft campus with a 25,000 sq. ft built-up area, featuring an 8,000 sq. ft Class 10,000 (ISO Class 7) clean room & Laminar air ow with Class 100 (ISO Class 5). This controlled environment maintains particle levels below 352,000 particles (≥0.5 µm) per cubic meter, ensuring strict sterility and biocompatibility essential for medical device manufacturing. Our facility is equipped with advanced machinery, in-house laboratory and instrumentation setups, and dedicated R&D units. A team of highly skilled and competent professionals ensures precision, consistency, and uncompromised quality in every product we manufacture.

Our Foundation

BUILT TO LAST

Zichor Life Tech operates from a state-of-the-art biomedical research and manufacturing infrastructure designed to support development, validation, and commercialization of next-generation hemostatic solutions. Our facilities meet the highest international standards combining clean-room manufacturing, advanced analytical laboratories, and dedicated clinical simulation spaces under one roof.

Core Capability

PRECISION AT SCALE

From raw material sourcing to finished product release, every step of our process is governed by a rigorous quality management system. Our infrastructure is built not just to produce but to ensure every unit that leaves our facility performs exactly as designed in the most critical moments a surgeon will face.

01

Clean-Room Manufacturing

ISO Class 7 and 5 certified clean-room environments for contamination controlled production of all hemostatic products and their components.

02

Analytical Laboratories

In-house testing for biocompatibility, sterility, shelf-life, and mechanical performance reducing time from bench to market without compromising rigor.

03

Cold Chain Logistics

End-to-end temperature-controlled distribution infrastructure ensuring product integrity from our facility to the operating room, every time.

04

Digital QMS Platform

Fully digital quality management system covering document control, CAPA, deviation management, change control, and supplier qualification.

ISO

13485 Compliant QMS

Our quality management system is built to ISO 13485 the gold standard for medical device quality assurance globally.

GMP

Manufacturing Standard

All manufacturing processes adhere to Good Manufacturing Practice guidelines as defined by international regulatory authorities.

24/7

Quality Monitoring

Continuous environmental monitoring, automated batch record review, and real-time quality data dashboards always on.

Our R&D pipeline is grounded in a structured, phase-gated development process from in- vitro proof-of-concept through pre-clinical animal models to clinical validation in human surgical cases.

Research Foundation

SCIENCE FIRST

No Zichor product reaches commercialization without rigorous, independent evidence of safety and efficacy. We collaborate with leading academic medical centers, hemostasis research laboratories, and clinical investigators across India and globally to ensure our science is both cutting-edge and clinically relevant. Our development process is physician-led at every stage from identifying unmet clinical need through designing study endpoints that reflect what actually matters to a surgeon at the table under pressure.

Coagulation-Independent Hemostasis

Developing active hemostatic agents that achieve rapid clot formation independently of the patient's own coagulation cascade enabling effective bleeding control in anticoagulated, thrombocytopenic, and coagulopathic patients.

Topical Bioadhesive Hemostats

Engineering next-generation tissue-adhesive hemostatic dressings with superior wet-surface adhesion, biodegradability, and zero foreign-body reaction for both open and laparoscopic applications.

Certification is not a checkbox it is the foundation of our promise to patients, clinicians, and healthcare systems. We pursue the most rigorous international regulatory standards as a reflection of our commitment to safety and quality.

Our Standards

Our certifications span manufacturing quality, product performance, biocompatibility, and sterility covering every dimension of what it means to produce a safe, effective medical device that a surgeon can trust in the most critical moment of a patient's care.

Certification is ongoing, not static. We maintain an active post-market surveillance program and conduct regular internal and external audits to maintain compliance at all times.

Quality Management

ISO 13485:2016

Medical devices quality management systems. Our QMS is designed, implemented, and maintained to meet the full requirements of ISO 13485 — covering design controls, production, post-market surveillance, and customer feedback.

Regulatory Compliance

CDSCO Registration

Our products are developed and registered in compliance with the Central Drugs Standard Control Organisation requirements under the Medical Devices Rules, 2017 — India's primary medical device regulatory framework.

Biocompatibility

ISO 10993 Series

All Zichor hemostatic products undergo comprehensive biocompatibility evaluation per ISO 10993, including cytotoxicity, sensitization, irritation, and systemic toxicity assessments prior to any clinical use.

Sterility

ISO 11135 / 11137

Sterilization validation performed per ISO standards for ethylene oxide and radiation-based processes, ensuring every product reaches the surgical field in a validated sterile state without exception.

Manufacturing

Schedule M GMP

Our manufacturing facilities comply with the revised Schedule M Good Manufacturing Practice guidelines, ensuring pharmaceutical-grade manufacturing rigor is applied to all hemostatic products we develop.

International Markets

CE Mark In Progress

CE marking under EU MDR 2017/745 is actively being pursued for key products, enabling entry into European healthcare markets and demonstrating alignment with the world's most stringent device regulations.

Our goal is not just to achieve certification but to maintain it with integrity, year after year. Every audit, every deviation, and every corrective action is an opportunity to make our quality system stronger and our products safer.

ISO+

Scroll al inicio