BIOZENITH LTD

Regulatory & Technical Consulting for Medical Devices and Life Sciences

Specialized regulatory, quality, and technical consulting for medical device manufacturers and life sciences organizations operating across international markets.

UK Registered | Company No. 17214434 | England and Wales

About

A UK-registered consultancy for regulated industries

BIOZENITH LTD is a UK-registered consultancy specializing in regulatory affairs, management advisory, and technical IT services for the medical devices and life sciences industry. The company provides consulting on regulatory submissions, market access strategy, quality management systems, and supporting IT solutions for medical device manufacturers and life sciences companies across international markets.

Legal name
BIOZENITH LTD
Company number
17214434
Incorporated
12 May 2026
Jurisdiction
England and Wales
Entity type
Private company limited by shares

Leadership

Founded with deep regulatory expertise

Founder & Director

The founder of BIOZENITH LTD is also the founder of Shanghai BIOZENITH Medical Science Co., Ltd (USCC: 91310120MA1JJP6T3F, established May 2021), leading medical device regulatory consulting operations in China.

BIOZENITH LTD, established May 2026 — five years after the founding of the Shanghai operation — extends the founder’s regulatory expertise to international markets. Areas of practice span major regulatory frameworks including the European Union (MDR/IVDR), the United Kingdom (UKCA/MHRA), and China (NMPA).

Services

Three areas of focus

Each engagement is led directly by senior regulatory expertise. We work alongside in-house regulatory, quality, and engineering teams — from early-stage strategy through post-market obligations.

Medical Device Regulatory Submissions & Strategy

  • EU MDR / IVDR technical documentation
  • NMPA registration support for China market
  • UKCA / MHRA registration for UK market
  • Pre-submission strategy and gap analysis
  • Post-market surveillance and vigilance reporting

Quality Management Systems (QMS)

  • ISO 13485 QMS implementation
  • ISO 14971 risk management framework
  • CAPA system design
  • Internal audit preparation

Medical Device Software Compliance

  • Software as a Medical Device (SaMD) compliance consulting
  • Technical documentation for software-driven devices
  • Regulatory document workflow systems

Our Approach

Phased regulatory consulting, end-to-end

Engagements follow a structured delivery framework, sequenced to align with regulatory milestones and to give clients visibility on timeline and risk at every stage.

01

Gap Analysis

Initial regulatory and quality system assessment against target market requirements.

02

Strategy Roadmap

Customized regulatory pathway with timeline, deliverables, and risk mitigation.

03

Submission & Implementation

Hands-on support through technical documentation, dossier preparation, and authority interactions.

04

Post-Market Support

Ongoing obligations including vigilance reporting, periodic safety updates, and lifecycle management.

Contact

Get in touch

For new engagements and regulatory enquiries, please contact us via our registered office in the United Kingdom. We respond to all correspondence within two working days.

Registered Office

Unit A, 82 James Carter Road
Mildenhall, Suffolk, IP28 7DE
United Kingdom

Company Number

17214434
Registered in England and Wales