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.
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 IND and NDA Application Documents
Flexible and Customizable Registration Application Document Preparation Service
Review of Guidance on the Documents Preparation
On-Site Review of Guidance on the Drug Registration
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
Project Demonstration During Project Technology Development or Transfer
Analysis of IND/NDA Application Strategy
Research and Assessment of Special Varieties
TEL: +86-523-86285566
Address: Building 29, No. 801, Jiankang Avenue, Taizhou, Jiangsu
Email: BD@yaohaibio.cn
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