BDRC has partnered with an expert consulting firm in China and can offer various services to assist excipient (and API) manufacturers with their Chinese Registrations (Master Files), translations and comparisons of the Chinese Pharmacopeia (ChP 2020) monographs and general chapters related to their products and verifications that their products are compliant to ChP 2020. We can also act as an In-Country Agent for excipient (and API) companies who may not have their own facilities in China. The various types of services which can be provided are listed below. However, other services can be provided as well based on your need.
Consulting & Chinese Excipient Registration Services
English Dossier Preparation assistance and Project Management by BDRC
Excipient (and API) Registration Dossier Templates are available, if Client chooses to utilize them to develop their registration dossier
Project management of dossier filing between Client, BDRC and In-country Agent
Answering questions regarding registration filings
Review of Client’s filing documentation and suggestions for improvement associated with the experience in the market
Dossier Preparation in China by Agent
Monthly reporting of progress of registration document preparation and submission
Additional meetings with Client to be scheduled on an as needed basis to discuss filings
Review product for registration and determine if similar products are registered
Prepare the submission package including completion of forms, Chinese translation, proofreading translation, print and copy documents (electronic as necessary)
Submit documents to CDE including initial submission, follow-up on progress
Dossier Submission and Maintenance
Local meetings with the CDE, as needed.
Prepare and submit supplementary document packages (if required)
Once completed, provide registration number and final copies of documents
Advise on Regulatory Changes
Advise on best practices associated with experience in filings.
Submission of LOA
Electronic submission to the portal
Annual reports
Post-Dossier submission
Amendments – Supplier Changes and CDE changes
Chinese Pharmacopeia (ChP 2020) Compliance Consulting Services
In addition to the services in connection with the Chinese Registrations BDRC also offers ChP 2020 compliance consulting services to help clients technically assess their excipients (and APIs) and verify that their products are compliant with the Chinese Pharmacopeia (ChP 2020). It will be vital for any excipient, API or pharmaceutical company having products in the Chinese market to ensure compliance with the current Chinese Pharmacopeia. The services which BDRC can supply include the following
Chinese to English or English to Chinese translation of ChP monographs, general chapters or other documents can be provided as needed.
Technical comparisons of ChP 2020 monographs and general chapters to ChP 2015 monographs and general chapters
Technical comparisons of ChP 2020 monographs and general chapters to monographs and general chapters in various other global pharmacopeias (USP-NF, Ph.Eur, JP, etc.)
Evaluation of test method equivalence between monograph requirements in ChP 2020 and relative test methods in other global pharmacopeias
Development of strategies for achieving test method equivalence between ChP 2020 and other global pharmacopeias
Validation and verification of test methods and results related to ChP 2020 compliance using local labs in China
Compilation of supportive reports to demonstrate ChP 2020 compliance that can be used in China Excipient (and API) Registration Dossiers
Detailed Cost Estimates can be provided to the Client based on the specifics of the project requested and the number of products anticipated to be included in the project.
Use the contact Form on the Home or contact Page to request further information
We have helped a number of companies with these Registration, Evaluation and Translation Projects in China! Contact us to see if we can help you!