Newlystar-medtech has a strong technical support team which is responsible of registration, GMP inspection and consultation, manufacturing surveillance and complaint handling. All the team members are pharmacists who can provide professional services for customer.
Being a professional team with very rich experience on the following aspects:
1) We are capable of providing effective registration documents and necessary assistance on other relevant regulatory affairs during each stage of the projects. We have already obtained registration licenses for many products in Colombia, Venezuela, Mexico, Peru, Chile, Uruguay, Thailand, etc.and we are now carrying out projects in GCC countries.
2) Also, we supervise pharmaceutical plants to improve their GMP level and quality assurance system, help them achieve GMP certificate from foreign countries. We have already helped 7 pharmaceutical plants to pass GMP inspection and achieved GMP certificate from INVIMA of Colombia, also have experience in GMP inspection for food and drug administration of Brazil-ANVISA , of Cuba, GCC and African countries, etc.
3) We handle the complaints from our customer, by efficiently coordinating plants to do investigation and analysis, so that final root cause can be found and corrective action can be done timely.
4) Now we are also focusing on providing sevices on regulatory affair for Chinese market since our import development of good pharmaceutical finished products into China.