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CambReg Partner with Leading Indian Based CRO
Cambridge Regulatory Services (CambReg) has formed a strategic alliance with SIRO Clinpharm, a leading global Indian based Clinical Research Organisation to provide pharma companies in both Asia and Europe with both regulatory expertise and ability to conduct fast paced trials, according to the companies.
“This partnership will provide European pharma companies with increased confidence in accessing cost effective clinical trial solutions, hence introducing new clients to SIRO. In return SIRO will have the benefit of offering regulatory expertise through CamReg,” commented Karen James, Managing Director of Cambridge Regulatory Services.
"Our alliance with CambReg would go a long way in helping small and mid-sized companies cut through the regulatory maze in Europe" said Dr Chetan Tamhankar, Chief Operating Officer of SIRO Clinpharm.
"This alliance builds on the strength of our European clinical trial operations and allows us
by Gwyneth Astles
NEWSASIA NEWSASIA NEWSASIA NEWSASIA
JiangXi Guo Yao Factory Passes FDA Inspection
ChemWerth, a supplier of active pharmaceutical ingredients to generic drug manufacturers, is pleased to announce that its partner, JiangXi Guo Yao (Guo Yao) pharmaceutical facility has passed an FDA overseas inspection.
Guo Yao’s main products exported to the US include Lincomycin HCl and Oxytetracycline HCl. ChemWerth and Guo Yao supply Lincomycin HCl worldwide.
Karen James and Dr Chetan Tamhankar to offer greater value to our clients." he added.
The new alliance will offer full regulatory services to pharma companies wishing to register human medicines, including new small molecule or biotech entities, Biologics, Herbals and Generics.
TO FIND OUT MORE CIRCLE NO. 303
ChemWerth and Guo Yao have collaborated since 1987. Guo Yao was one of the first Chinese factories to supply FDA approved Active Pharmaceutical Ingredients (APIs) to the United States. Guo Yao continues to be a primary supplier of high quality APIs to the Chinese and US markets. ChemWerth also reported that the FDA inspection of Guo Yao cited two minor 483 deficiencies, both of which are being promptly addressed at the facility.
According to Mr. Peter Werth, ChemWerth CEO,
“We are very pleased that another one of our partner factories has been successful in passing an FDA inspection. Our regulatory expertise in helping manufacturers like Guo Yao get approved is a real value-added benefit for our customers. We’re proud to have Guo Yao as a manufacturing partner for over 22 years.”
TO FIND OUT MORE CIRCLE NO. 304 ERT Appoints New Associate Director of Business Development - Japan
Japan, Miki Stevens. Ms. Stevens will report to the Senior Vice President of Strategic Marketing, Planning and Partnerships. In this new role, Ms. Stevens will work with ERT’s Japanese partner, Site Support Institute (SSI) to facilitate sales activities and enhanced in-country support of Japanese sponsors and clinical trial sites.
Miki Stevens
ERT, a leading provider of centralised ECG, ePRO and other services to the biopharmaceutical, medical device and related industries, announced the appointment of a new Associate Director of Business Development -
Ms. Stevens has dual Japanese and American citizenships and speaks and writes fluent Japanese and English. She has a Bachelor of Arts degree from Tufts University (Boston) and has built up extensive project management and business development experience, including timeline management, budgeting resource allocation and marketing strategy. Ms. Stevens will assist in all aspects of developing and executing Japanese and other regional Asian strategic initiatives and partnerships working in collaboration with ERT sales, operations and other relevant departments.
Ms Stevens joins ERT from Parexel International Inc (Tokyo) where she worked as an Account Manager in Business Development. In this role, Ms. Stevens managed relations with biopharmaceutical and medical device clients and successfully launched the marketing department. She previously served as a Senior Clinical Research Associate for Ophthalmic Research Associates (Massachusetts, USA), where she was project leader of clinical trials.
Robert Brown, SVP, Strategic Marketing, Planning and Partnerships at ERT, comments, “We are delighted to welcome Miki to the ERT team. This new appointment continues our investment in the Japanese and wider Pacific Rim markets helping us to expand our direct sales reach and service the needs of our clients in the best possible way. We strongly believe this appointment will further improve and enhance the quality of our services in this market.”
TO FIND OUT MORE CIRCLE NO. 305
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