Global Regulatory Affairs Platform

Providing high-quality, efficient, and accurate regulatory support for domestic and international IND, BLA, and related submissions

Our Services

Expert Regulatory Guidance

Yaohai Bio-Pharma has deep expertise in global regulatory requirements, providing strategic guidance throughout the product lifecycle. We support rapid project advancement and offer full-spectrum services, including CMC consulting, CTD preparation, regulatory liaison, inspection support, and regulatory training and advisory meetings.

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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

End-to-End Regulatory Support

01.

CMC Regulatory Consulting

01. CMC Regulatory Consulting

Domestic and international CMC strategy, regulatory consultations, and submission support

02.

Regulatory Documentation Writing

02.Regulatory Documentation Writing

IND/NDA dossier preparation and customized regulatory documentation

03.

Regulatory Intelligence & Strategy

03.Regulatory Intelligence & Strategy

Global regulatory research, strategy guidance, and one-on-one consultation

04.

On-Site Inspection Support

04.On-Site Inspection Support

Preparation and support for regulatory inspections

05.

Evaluation & Technical Support

05.Evaluation & Technical Support

Project evaluation, submission strategy, project-specific review

06.

Project Management

06.Project Management

Project management and regulatory coordination
Why Choose us

Accelerating Your Drug Approval Process

We provide flexible, end-to-end microbial CRDMO solutions, backed by extensive project experience, a professional team, and full GMP-compliant production capabilities.

Expert Team Support

Over 15 years of drug registration and project management experience.

Extensive Project Experience

Served 300+ clients, accelerating regulatory approvals.

Real-Time Information Sharing

Up-to-date regulatory insights via official channels and databases.

End-to-End Lifecycle Services

One-stop support from development to IND/NDA submissions.

Comprehensive Project Management

Professional planning and guidance throughout projects.

Implementable Solutions

Tailored, actionable solutions for smooth project progress.

WANT TO LEARN MORE?

Discover Our Expertise

Explore our tailored CRDMO services and innovative solutions designed to support your biologics development from concept to commercialization.

CRDMO Modalities

provide one-stop CMC solutions for biologics, with a strong focus on recombinant proteins/peptides, plasmid DNA, nano-bodies, novel recombinant vaccines, and therapeutic plasmids. Our services are driven by customer needs—efficient, flexible, and reliable.

CRDMO Solutions

We provide comprehensive CRDMO services—from process development, IND-CMC studies, and GMP manufacturing to NDA submission and MAH-based commercial production—enabling the full journey from DNA to commercialization.

News&Article

Access the latest updates on company news, events, and technical articles.

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.