Registration

Service Overview

With the experienced drug registration application service team, Yaohai Bio-Pharma provides high-qualified, efficient and accurate registration services including IND/BLA application home and abroad, CMC consultation, registration application strategy guidance, preparation and submission assistance in CMC-related CTD documents, communication assistance with official authorities, on-site inspection guidance, training and conference on drug registration regulations organization. The core members of the registration team have abundant registration experience, in-depth understanding of registration-related regulations in China and aboard, and provide comprehensive guidance on regulations and strategy in full life cycle of product development.

Services

Registration Service

Committed to CMC Regulatory Consulting Services

Provide Guidance on CMC Strategy Making and Gap Analysis for Domestic and International Registration Applications

Assist in Communicating with Regulatory Authorities, Responding to Approval Comments and Submitting Supplementary Documents

Assist in Communication on Matters Related to Registration and Inspection

Assist in the Collation, Review, Filing, Binding, Submission, etc. of Registration Application Documents

Organize Meetings, Including CDE Consulting Meetings of Types 1, 2, and 4 as well as Other Meetings (Including the Submission of Meeting Requests, Preparation of Meeting Documents, and Attend the Meeting to Assist the Customers in Communicating with the Regulatory Authorities)

Preparation of Application Documents

Preparation of IND and NDA Application Documents

Flexible and Customizable Registration Application Document Preparation Service

On-site Inspection

Review of Guidance on the Documents Preparation

On-Site Review of Guidance on the Drug Registration

Regulatory Support Matrix

Research on Regulations from Drug Regulatory Authorities Worldwide

Regulatory Strategy & Implementation Guidance

Sorting and Interpretation of General Regulations and Individual Regulations

Year-Round Routine Regulatory Consultation

One-to-One Regulatory Consultation

Project Management

Other Value-added and Special Services

Project Demonstration During Project Technology Development or Transfer

Analysis of IND/NDA Application Strategy

Research and Assessment of Special Varieties

Service Advantages

Professional Team

The core members have rich experience in drug registration and project management for over 10 years. Multi-module expertise, numerous professional operation experience, and strong professional support from domestic and foreign experts.
Abundant Project Operation Experience

Have served more than 200 customers. We pre-evaluate the difficulties of projects and improve project efficiency significantly on the back of abundant project experience and skilled understanding of regulatory guidelines, review requirements and drug registration points.
Real-time Information Sharing

Familiar with every communication channel of official authorities, we timely grasp the latest regulatory trends, fully understand the laws and regulations, and share the information after integration and analysis with a powerful regulatory database and document template database.
Full Life Cycle Service Management

One-stop service chain, covering the establishment of R&D system, IND and NDA application, and project management. Implement the full lifecycle of drugs management concept in the full course of the project.
Project Management Improvement Service

Provide full life cycle planning and guidance service and feasible suggestions, focus on risk management and budget control, formulate practicable solutions to ensure project quality.

Professional Team

Abundant Project Operation Experience

Real-time Information Sharing

Full Life Cycle Service Management

Project Management Improvement Service

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