Quality Assurance Service Platform

Quality-Focused, GMP Compliant, Efficient, and Collaborative

Our Services

Quality Assurance
is the Lifeline of Yaohai

Yaohai Bio-Pharma provides comprehensive quality management services focused on client satisfaction, including IND and clinical-stage sample preparation in compliance with FDA, EMA, and NMPA standards, as well as full-spectrum quality management for commercial-stage drug production under NMPA requirements.

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Reach out to learn how our microbial CRDMO services can support your project.

What we do

We made the world with technology

01.

Microbial Strain and Cell Bank Construction

01. Microbial Strain and Cell Bank Construction

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02.

Upstream&Downstream Process Development

02. Upstream&Downstream Process Development

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03.

Formulation Process Development

03. Formulation Process Development

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04.

Quality Research and Analysis

04. Quality Research and Analysis

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What we do

Robust Quality Assurance System

01.

Integrated Quality
Management

01.Integrated Quality
Management

Quality management across the drug development lifecycle, from R&D to commercial production

02.

Regulatory Compliance

02.Regulatory Compliance

Strict adherence to global regulations and CMC requirements

03.

Quality System
Optimization

03.Quality System
Optimization

Building and improving quality systems for long-term excellence

04.

Inspection & Compliance Oversight

04.Inspection & Compliance Oversight

Through inspection, coordination, and supervision, ensuring data integrity, compliance, and proper documentation

05.

On-Site Guidance

05.On-Site Guidance

Expert guidance on laboratory compliance, equipment qualification, computerized systems, and regulatory inspection
Why Choose us

Comprehensive Documentation System
Across 9 Key Areas

Quality Management & Assurance

Organization & Personnel

Facilities & Utilities

Equipment Management

Materials & Products

Qualification & Validation

Documentation Management

Manufacturing Management

Laboratory Management

WANT TO LEARN MORE?

Quality Assurance & Regulatory Excellence

Documentation Control

Yaohai Bio-Pharma has established a robust documentation control system to ensure standardized and consistent operations.

POL: Management Policies SOP: Standard Operating Procedures
STP: Process Flows, Quality Standards, and Testing Procedures
Forms: Records with numbering aligned to SOPs and STPs, independently approved

Regulatory Support

Yaohai Bio-Pharma partners with top international GMP consulting firms and FDA experts to continuously optimize its quality system and resolve operational challenges.

FAQ

Frequently Ask Questions

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Ut fames nibh euismod fermentum justo velit ultricies nunc duis placerat taciti. Torquent quam nisi integer fermentum accumsan litora. Efficitur potenti hac imperdiet laoreet vel vivamus placerat platea augue taciti. Dictum ultricies efficitur metus aliquet consectetuer pulvinar vivamus eget.

Ut fames nibh euismod fermentum justo velit ultricies nunc duis placerat taciti. Torquent quam nisi integer fermentum accumsan litora. Efficitur potenti hac imperdiet laoreet vel vivamus placerat platea augue taciti. Dictum ultricies efficitur metus aliquet consectetuer pulvinar vivamus eget.

Ut fames nibh euismod fermentum justo velit ultricies nunc duis placerat taciti. Torquent quam nisi integer fermentum accumsan litora. Efficitur potenti hac imperdiet laoreet vel vivamus placerat platea augue taciti. Dictum ultricies efficitur metus aliquet consectetuer pulvinar vivamus eget.