What RegAff can do for you in China

Development→Marketing Application→Post-Approval

RegAff has a Local Company:
RegAff (Beijing) Medicinal Science & Technology Ltd that can act as your agent to:

• Define strategy, consult and negotiate with SFDA in China for a local
• regulatory clinical development program
• Create the clinical trial dossier
• Submit a registration application
• Follow up to obtain approvals
• Manage clinical studies
• Create marketing application dossiers and negotiate SFDA approval
• Help find companies to license the product.

End result:
Provide a much stronger negotiating position for licensing-out by having a product with marketing approval rather than in the development stage AND without having a company or resources in a country by use of RegAff’s local company.
All such activities have the potential to raise companies’ stock price and market capitalization.

• Clinical trial applications
• Marketing applications
• Smarter regulatory development strategy and negotiation
• Smarter line extension strategy development and registration operations
• Clinical studies
• Chinese local dossier creation and e-Publishing
• License maintenance
• Pharmacovigilance
• Chief Medical Officer (from Singapore)
• Licensing/acquisition strategy development and registration operation
• Chinese registration status information providing and analysis

Or
If you choose to market it yourself, enable you to have product ready to market before you build a sales and marketing organization, in order to save time and patent life and maintain the product license.

If needed, easy communication through EU and US based RegAff leadership members or go direct to:

Beijing Office:

Yun Zhong, B.med, MSc (Pharmacy)
15 years experience in leadership positions with China pharmaceutical regulatory (Bayer, AstraZeneca and Johnson & Johnson)
Good oral and written English
yun.zhong@regaff.com
Tel: +86-35-0198-8504

Singapore Headquarters:

Dr Melvyn Teillol-Foo, MBChB, FFARCS(I), FRCA, DipPharmMed (UK).
Established global bridging activities and supported regulatory in Asia with SmithKline Beecham, Pharmacia and Daiichi Pharmaceutical Company. Globally experienced, Singapore-based Chief Medical Officer that can handle any SFDA development clinical study requirements and, if required by the Client, product complaints and adverse reaction reports during marketing.
melvyn.foo@regaff.com
Tel: +65-8233 2778