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Regulatory Affairs

Define regulatory strategies to place devices on regulated markets. Prepare technical documentation for regulations such as Indian MDR, EU MDR, US FDA 510K.

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Clinical Trials & PMCF

Prepare clinical evaluation reports for submission to regulatory bodies. Design and implement clinical trials and PMCF

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QA & Regulatory Support

Implement and maintain a quality system as per applicable regulatory requirements. upport to update documentation including Technical Files, Quality Manuals, Procedures, Protocols and Formats

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Welcome to Alceon

A Division of Eupraxia Centre For Clinical Excellence LLP

Alceon was founded to fill the gap of providing genuine consulting support to medical device manufacturers who want to tap the world market. During the professional stints, the founder of the organization found a dearth of consultants who are knowledgeable, have the requisite industry experience and who can guide manufacturers without following a 'copy-paste' approach.

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Our Services

A Division of Eupraxia Centre For Clinical Excellence LLP

Regulatory Affairs

Define regulatory strategies to place devices on regulated markets.

QA & Regulatory Support

The QA function performs immensely critical duties in medical device companies

Post Market Surveillance Service

Post Market Surveillance is the single most crucial activity that an organization

Trainings

We can provide you both online and onsite training on a variety of subjects concerning regulatory

Design & Development

We at Alceon can provide you with the support to maintain your design and development files

Biosafety Evaluation

Biological evaluation of a device is a critical design consideration for manufacturers.

Our News

Our Leadership Team

A Division of Eupraxia Centre For Clinical Excellence LLP

Dr. Prashant Kirkire

(Founder)

A Ph.D. in Statistics and a post-graduate from MSU Baroda and the Indian Institute of Management Bangalore, he has over 30 years of experience in the industry. He chaired the Council for Clinical Data Management, Biostatistics and Medical Writing at ISCR between 2015-2018. He is the founder of Eupraxia and had held senior management positions in Pfizer Global R&D, inVentiHealth and IQVIA.

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Contact Us

A Division of Eupraxia Centre For Clinical Excellence LLP

+91 95121 90010

info@alceon.in

201-203, Tilak Complex, Pizza Bell–Midtown Heights, Near Vallabh Chowk, Jetalpur Road, Vadodara-390007. Gujarat, India.