CMC Quality Research and Drug Registration

Provide a one-stop comprehensive CRO service platform for CMC pharmaceutical quality research and analysis testing throughout the entire lifecycle of pharmaceutical research and developmen, involving various analytical method development of starting materials, intermediates, API and DP; Provide CMC Quality Research and Consistency Evaluation for generic products; Provide research on various topical drug products; Provide writing of registration articles, etc.

 

服务内容

● Ion Chromatography

● CAD/ELSD/FLD/RID Method Development and Validation

● Chiral Impurities

● Related Substances

● Forced Degradation Studies

● Stability Indicating Method (SIM) Development

● Assay

● Residual Solvents

● Water Content

● Microbial Method Development and Validation(Microbial limit, Bacterial Endotoxins)

● Chemical Residue Validation

● CMC Quality Research and Consistency Evaluation for Generic Products

● Topical Drug Products Study: In Vitro Release and Permeation, Contain Method Development and Validation

● Writing of Drug Registration Articles

服务流程

Q&A
 
Our Advantage
Authoritative qualification
NOA has been approved by Certification and Accreditation Administration of the People’s Republic of China(CNCA)(CNCA-R-2002-051), and has obtained qualification of China Inspection Body and Laboratory Mandatory Approval (CMA),and has passed the multiple approvals of China National Accreditation Service for Conformity Assessment (CNAS), International Accreditation Service (IAS), United Kingdom Accreditation Service (UKAS), Joint Accreditation System of Australia and New Zealand (JAS-ANZ). NOA has been approved by State Administration for Market Regulation of China, and has been recognized as inspection and testing institution of China's special equipment, as well as the qualification of China's national equipment supervision and engineering supervision. NOA-DCI is the notified body of the CE directive of the European Commission. NOA has been recognized by the International Electrotechnical Commission (IECQ) by obtaining Electronic Component Quality Assessment System. It is also a national inspection and assessment notified body of import and export commodity in China.NOA is a high-tech enterprise in Shanghai.
Improve Performance, Realize Asset Value Appreciation, and Service Throughout the Entire Value Chain
From pre-design to post-operation, NOA has the ability to guarantee the whole life cycle of the business. NOA, as an independent third-party inspection company, has a large number of domestic and international standards and specifications proficient in design, welding, non-destructive testing, painting, packaging and other fields The experienced team of professional engineers and inspection experts, with more than ten years of experience in the domestic market, is familiar with all aspects of the domestic industrial equipment supply chain, and can provide you with technical support services for the full life cycle of technical services in a timely manner, combining various products. Inspection, certification, testing, consulting, and auditing services can provide you with one-stop all-round comprehensive services.
Quality, Efficiency and Service
NOA has formed a mature and solid operation system in the development of more than 20 years. We let technical experts who are familiar with market regulations and testing standards and have professional industry experience to carry out inspection, evaluation and design review work. While meeting the requirements of domestic and international standards, we ensure that customers can obtain satisfactory service results in the first time with accurate time-sensitive management methods, and ensure that customers can seize the opportunity in the market competition.
Service Area
NOA inspection services currently cover Europe, Australia, Russia, some Middle East regions and most regions in China. NOA can ensure the consistency and continuity of customer service in different regions, and eliminate the impact of unfamiliar environments on customer quality. The guarantees and the impact of project implementation enable customers to participate in different markets across the country or around the world with flawless quality.

Tel:+86-400 821 5138

Fax:+86-21 3327 5843

Email:noa@noagroup.com

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