The consistency and integrity of world-standard quality control and regulatory compliance remain a big challenge for API sourcing.
Our contracted third party testing laboratory-Rainbowlabs complies with the highest international quality standards and serves global leaders from pharmaceutical industries with its testing, regulatory and CMO services. Rainbowlabs has gradually obtained the highest level of accreditation and certification from both international and domestic companies by continuously improving its quality management system and testing capabilities.
Rainbowlabs was inspected and approved by the U.S. FDA in Jul. 2013 and re-inspected in Jun. 2016 with Zero 483 issued. Serving as a dedicated QC center with the world highest qualification, we are offering to the global pharmaceutical industry FDA standard QC testing & release control, on-site QA back-up, API & formulation R&D, regulatory support, supply chain and risk management. As an ISO9001-certified CRO company, we welcome API sourcing, contract testing, R&D, and toll manufacture opportunity of APIs and formulations.
FLAGSHIP TESTING SERVICES
Our quality team is staffed by experienced and dedicated professionals. The COAs issued by this team have been well accepted by the top pharmaceutical companies in the U.S., EU, and Canada.
COMPLETE SOURCING AND DEVELOPMENT SERVICES
We pride ourselves on our ability to bring innovative ideas and solutions to market, leveraging our extensive knowledge, experience, and relationships in the pharmaceutical industry to consistently exceed our partner’s expectations.
Here are some examples of the services we can provide:
Contract laboratory testing services
Source qualification
Technology transfer
API/Dosage R&D
FDA/CEP Regulatory Support
cGMP/EHS Auditing Services
Management of CAPA, Change Control, Deviation, OOS and Complaint
Logistics and Supply Chain Management
RESEARCH AND DEVELOPMENT
We are actively engaged in new API discovery, commercialization, and new drug development with our strategic partners, and welcoming all CRO and CMO opportunities.
We are committed to delivering new pharmaceutical, nutraceutical and cosmetic raw materials and formulations. With teams located in the US and China, we have the capability to accommodate international contract manufacturing...