Services
Our CSR Services and Solutions are primarily focused on Commercialization and not on the Discovery stage. Through our wholly-owned R&D subsidiary, we provide clinical research and other essential Product Development services at the R&D stage. Please see www.chemsunicidr.com for IND services in China and greater China region.
For the Commercialization Stage...
Our Commercial team includes marketing, sales, regulatory, Quality/ Compliance, pharmacovigilance, legal and business development experts. We provide North American companies with access to the China and Greater China markets for its raw materials and finished products. We are familiar with the key players in the North American and Greater China markets, which include manufacturers, distributors, health insurance companies. Our expertise lies in the FDA-regulated products, specifically, drugs, biotech, devices, health and medical food products, as well as animal products
CSR: A Powerful and Invaluable Connection between U.S. and CHINA Markets
Our Business experts specialize in assisting customers in U.S. and China with services:
- to identify potential candidates at the R&D stage for licensing in their pipeline portfolio
- to identify potential buyers for specific technology, scientific know-how, products, specialty raw materials
- to identify potential partners for co-development, co-marketing and other such business relationships
- to identify potential partners for alliances, mergers, joint-ventures
We provide in-depth analysis of market, potential competition, legal and regulatory issues. During the lengthy interactions between multi-companies, we are able to coordinate and actively support your negotiations up to contract completion. Post-contract completion, we can provide operational support for all issues with our on-the-ground staff in U.S. and China. Our Regulatory experts offer many years of experience in interacting and negotiating with different review Divisions at the FDA Centers in Washington, D.C., and have participated in many FDA Advisory Committee Meetings.
Commercialization in North American and Greater China Markets
CSR Pharma Services is an independent marketing and sales organization, specializing in commercialization of products for the North American and Greater China markets, namely, U.S. , Canada and China. During the Commercialization Stage, you as the manufacturer and owner of your products have many regulatory and Quality/Compliance responsibilities that are enforced by the regulatory agencies. We can assist you in meeting your responsibilities cost-effectively by serving as your liaison with the regulatory agencies and as your office in North America or Greater China, such as during product recall and/or in the event of serious illnesses or deaths in the markets.
Supply Chain Security in Greater CHINA Region
We specialize in Supply Chain Security services for the Greater CHINA Region with office and on-the-ground operations in Shanghai. We can assist with supplier/vendor quality assurance to meet FDA standards and comply with FDA requirements through many and diverse services, including the following activities that may take place at the supplier/vendor sites:
- Compliance monitoring at events or milestones
- Compliance with Quality Agreement
- Assessment of Quality System and other FDA Inspection Systems
- Assessment of Validation / Verification programs for processes and methods
