Technical Consulting Services
Our company has a professional team specializing in pharmaceutical R&D, regulatory registration, and quality management. With extensive project experience, we can provide professional analysis, advice, and solutions to clients on pharmaceutical research and registration-related issues — such as project initiation investigation, RLD selection, quality studies, drug registration filing, and generic drug consistency evaluation.
We offer the following technical consulting services:
1. Project Initiation Investigation
Literature search–Search for domestic and international literature on pharmaceutics, pharmacology, toxicology, and clinical studies.
Document translation–Professionally translate regulatory submission documents from the FDA or EMA, and organize them into submission-ready dossiers.
Narcotic and psychotropic substance initiation application document–As a joint development partner, compile and draft the initiation application documents for narcotic/psychotropic substances, and assist applicants in initiating projects.
2. Registration Strategy Establishment
Identify the fastest drug registration pathway while avoiding patent ownership issues.
Evaluate the feasibility of product development and registration.
3. Application Dossier Review
Technical review–Organize internal teams and senior review experts to pre-assess the completeness and technical quality of the clients’ application dossier, provide revision recommendations, and work with the clients to make amendments and supplementary study updates.
Format review–Our regulatory specialists check the dossier for compliance with regulatory requirements and present a complete, compliant dossier to the clients.
4. Regulatory Issue Communication
Work with clients to analyze their registration issues and offer consulting solutions.
Support clients in seeking advice on complex issues, then organize and present the feedback to them.
5. Registration Submission Services
Registration Agency Services–Our drug registration team has years of hands-on experience in drug registration and R&D. We are familiar with the full development and submission procedure for innovative drugs. Our team regularly participates in training organized by NMPA, Jiangsu Medical Products Administration, and other official bodies, and has a deep understanding of domestic regulatory requirements and ICH guidelines. We offer registration agency services covering chemical drugs, biologics, medical devices, and imported drugs, providing efficient, high-quality support to meet all drug regulatory requirements.
Registration Submission Services–Including new drug registration, generic drug registration, quality and efficacy consistency evaluation, IND applications, supplemental applications, change record, re-registration, and API registration (including separate review).
6. Review Progress Tracking
After the submission, we track the progress of the dossier review, assist clients with on-site inspections and regulatory testing, and help them obtain final drug approval.
In the future, we will also provide domestic eCTD registration support in line with national eCTD technical requirements, helping the clients prepare and submit dossiers in eCTD format. Please feel free to inquire.Our company maintains good working relationships with many experts, scholars, and key opinion leaders (KOLs) across pharmaceutical R&D, manufacturing, and regulatory systems. This enables us to provide professional and authoritative guidance to help clients avoid unnecessary detours.
Keywords：
Technical Consulting Services
Recommended Products
Product Consultation
If you have any suggestions, please leave a message or send us an email. We will reply to you within one working day after receiving your message.
Please contact us for more detailed information.
Kangchuanji Pharmatech looks forward to working with you and jointly creating a bright future!
Follow us
Nanjing Kangchuanji Pharmatech Co., Ltd.
Contact Us：18020149597（HR）
Recruitment Email:recruit@kcjpharma.com
Address: 2nd Floor, Building 5, No.199 Wenfang Road, Jiangning District, Nanjing, Jiangsu Province, China（Jiangning High-tech Park）
Copyright © Nanjing Kangchuanji Pharmatech Co., Ltd.