Sinosource has established a drug registration department with a team of highly qualified staff specializing in the drug registrations of foreign countries. Registration regulation is similar but different from country to country. This situation increases the difficulty of registration. Through plenty of registration practice, our experienced team strives to find the common and different ground between USA and other foreign countries, and establish the common registration procedure for each product so that we can go through the registration process effectively to ensure our clients can achieve satisfactory and excellent business success.
As an important and necessary step, drug registration can strengthen and stabilize the drug exporting and importing process. In most cases, registration is compulsively governed by competent Health Authorities.
Only through professional preparation can registration be done successfully. In the process of registration, not only a full knowledge of multi-courses is required, including medicine, pharmaceutics, pharmacy, pharmaceutical engineering, biological engineering, microbiology, professional English, etc, but also GMP on-site management, which must be in compliance with relevant registration regulation in the importing country, is a must. In addition, registrars must be aware of the advances in science, technology, and registration regulations in every country and region, especially in USA, Europe and WHO organization.
What we can do
1) Compile CTD registration dossier, DMF and SMF in several languages
2) Coordinate on-site inspection with foreign MOH/FDA officials
3) Provide technical support for pharmacopoeia and cGMP compliance
4) Customize a registration program not only for export but also for import
5) Provide overall counseling service to occupy preemptive opportunity in the market
What we have done
1) Registered several biologicals successfully in India, Pakistan and Sri Lanka.
2) Submitted registration dossiers to 30+ countries and regions, such as Southern American PAHO, Brazil, Russia, India, Iran, Egypt, Philippines, etc.
3) Prepared common registration dossiers. English & Russian versions have been completed while Portuguese & Spanish versions are underway.
4) Established a training center for international drug registration to help other enterprises register their drugs in other countries. |
