Regulatory Affairs Services
Based on ICH guidelines, FDA and CDE requirements, Baolong can provide services on the International Pharmaceutical Registration Affairs. The services scope covers the whole life cycle of drug products including FDFs/ APIs /Excipients, and essentially, with no limitation to the countries where to file the product.
So far, by using the drug substances which have been imported by Baolong, 100% successful approval rate has been achieved for the corresponding drug products. Baolong’s highly capable RA team and well established process are the keys to the filing success.
Baolong’s focused Pharmaceutical products are as following:
- Innovative drugs, improved new drugs
- Generic drugs
- Imported APIs and formulations
- Imported excipients
Our Strength
Baolong’s speciallized AP supply platform provides high quality service of API to both domestic and foreigning pharmaceutical componaies.
1. NETWORK
Baolong’s current business partners includes the reknowned phamarceutical Companies which are from the US, Netherland, German ,Spain, Italy, India, and Japan.
2. TRUST
Strategic cooperation agreements have been signed intween Bolong with some of the business partners.
3. COMPLIANCE
Supplier management , regular paper audit /site audit
4. Regulatory Submission & Approval
- Feasibility assessment for domestic registration
- Documents Gap analysis
- Dossier translation, preparation, writing, submission
- Register QC testing
- registration progress tracking
- deficiency letter response and guidance
- annual report and registration maintenance
5. Confidentiality Measures
Bonglong is committed to protect customer's confidential information and Intellectual Property strictly. The IP protection system is established according to the international standard .
