Need For A Smarter Regulatory System To Ensure Access To Affordable Biologics: The Biosimilars

New Drug Approvals

by

Kiran Mazumdar Shaw, MD, BIOCON

The global pharmaceutical industry is going through a paradigm change as biologics such as monoclonal antibodies and recombinant proteins find greater acceptance for treating a wide range of chronic diseases.

Today biologics make for up half of the top 10 best-selling drugs worldwide.

http://kiranmazumdarshaw.blogspot.in/2013/08/need-for-smarter-regulatory-system-to_13.html

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CHUAN YAO Senior Consultant , Singapore

CHUAN YAO

Senior Consultant

Singapore

Pharmaceuticals

chuanyao1@gmail.com

Current	Professional Consultancy
Previous	Wyeth / Pfizer, Go Medical Industries Pty Ltd, Australia, Pacific Pharmaceuticals Ltd (Merck Group)
Education	Auckland University of Technology

chuanyao1@gmail.com

linkedin

sg.linkedin.com/pub/chuan-yao/27/b8/6a2/

25+ years of experience in the Pharmaceutical/Medical Device industry
Senior positions in the areas of Quality Assurance, Regulatory Compliance and Regulatory Affairs –Merck, Wyeth, Pfizer (China, New Zealand, Australia and Singapore)

Areas of Expertise

US FDA, CFDA, PIC/s, EU GMP and ISO(17025, 14971, 13485, 14644) Compliance
QA and Risk Assessment in Pharmaceuticals and Devices
Compliance Auditing and Gap Analysis
Regulatory Affairs and Compliance
GxP Training
Analytical Testing
Process Capability

chuanyao1@gmail.com

Chao wrote to me

Dear Anthony,

Thank you very much for adding me to your professional connection. I would like to introduce myself as I don’t have the pleasure to meet you personally.

My name is Chuan Yao, and I have had over 25 years’ experience in the pharmaceutical and medical device industry and have held senior positions in the areas of Quality Assurance, Regulatory Compliance and Regulatory Affairs. I have worked in the industry in China, New Zealand, Australia, Singapore and other ASEAN countries. I am currently working as a senior consultant for a consultancy company and am based in Singapore. My areas of expertise include –
 US FDA, CFDA, PIC/s, EU GMP, GxP and ISO Compliance
 QA and Risk Assessment in Pharmaceuticals and Devices
 Compliance Auditing and Gap Analysis
 Regulatory Affairs and Compliance
 GxP Training
 Analytical Testing
 Process Capability

I hope we can co-operate on a project and work together in the near future. Don’t hesitate to contact me for any questions or future request. Please keep in touch, My business email address is chuan.yao@chempharm.asia

Thank you !

Chuan Yao

\

Nice to know you through LinkedIn. Please see below my contact details.

ChemPharm is a professional full service consulting firm that has extensive practical expertise of supporting Pharmaceutical, Biotechnology, Medical Devices and Traditional Chinese Medicine (TCM) industries. ChemPharm is able to provide specialist expertise across all areas including: QA, QC, Production, Logistics, Product Development and Regulatory Affairs. Our Services include, review and remediation of existing GMP standards, development and implementation of Quality Management Systems, Validation Services, GMP/GDP/GLP Auditing including Pre-approval Inspection (PIA) and Supply Chain Auditing, DMF and product registration (especially in ASEAN countries and China).

ChemPharm consultants have extensive in-depth working knowledge and experience in International Regulations, Codes and Standards. This includes the major GMP regulations, codes and standards as follows:
◦PIC/S Part 1, Part 2 and Annexes
◦EU/UK EMEA, MHRA Eudralex Volume 4 (Orange Book)
◦CFDA
◦US FDA 21CFR Parts 210 and 211,
◦US FDA 21 CFR Part 11 (Computers)
◦US FDA 21 CFR Part 820 (Devices)
◦WHO Guide to GMP 2007
◦ASEAN Code of GMP
◦ICH Q1, Q2, Q7, Q9, Q10
◦ISO 17025, 14971, 13485,
◦Industry Guidance Documents (PDA, GAMP, ISPE)

We stay current with regulatory changes in the USA, Europe and Asia to ensure that it meets a truly upfront global perspective. We are based in Singapore but service our client globally.

I hope we can co-operate a project and work together in near future. Please don’t hesitate to contact me for any question or future request.

Kind Regards,

Chuan Yao
Principal Consultant
ChemPharm (S) Pte Ltd
21 Jalan Sempadan #03-08
Singapore 457398
Tel: +65 6699 9007
Fax: +65 6699 9008
Mobile: +65 9673 1061

Email: chuan.yao@chempharm.asia

Skype: chuanyao1