Asia/Pacific
Asia/Pacific
Regulatory agent
- Clinical trial applications
- Marketing applications
- Regulatory development strategy and negotiation
- Clinical study
- Dossier creation and e publishing
- License maintenance
- Pharmacovigilance
- Chief Medical Officer (Singapore based)
- Licensing/acquisition
Melvyn Teillol-Foo, MD
Malaysian born, educated in the UK including MD degree; 20 years plus experience including establishing bridging studies and supporting regulatory in Asia and forming a Clinical Pharmacology Experimental Medicine Clinic in Asia; has worked in the EU, US, Japan and Asia with SKB, Pharmacia, Daiichi and the CRO, Pharmaco-LCRC.
melvyn.foo@regaff.com
Tel: +65 82332778
RegAff Pte Ltd
SG Tel : +65 63296511
Yun Zhong, B.med, MSc (pharmacy)
15 years experience in leadership positions in Pharma regulatory (Bayer, AstraZeneca and J & J)
Good oral and written English
yun.zhong@regaff.com
RegAff (Beijing) Medicinal Science & Technology Ltd.
Room 1021, Pingfang Shouhang Fonda,
222-1, 1 Community
No.85, Yong Ding Road, Hai Dian District, Beijing,
PR China
Tel: +86-13501988504
John Kang, BSc (microbiology), MBA
• 25+ years experience in pharmaceutical companies and CROs
• Preclinical and Clinical R&D
• Registration of Rx, Generics, Agrochemicals, Medical Device and Diagnostic products
• Advisory Board Member of Bio Nano Division of Ministry of Knowledge and Economy in Korea since 2007.
john.kang@regaff.com
Sunitha Nalla, MSc(biology), MSc(computer science)
16 years experience in pharma regulatory and IT. Expert in e CTD.
sunitha.nalla@regaff.com
Shoichiro Hamano, PhD
More than 30 years experience in pharmaceutical and consumer health business with Taisho Pharmaceutical Co and own consultancy; including drug discovery, product formulation, technology transfer, licensing, business planning , mergers & acquisition.
s.hamano@regaff.com
Tel: +81-90-2767-4872
Other Asian countries
Singapore
RegAff is headquarted in Singapore.
The Health Services Authority(HSA) is a well respected by major regulatory authorities. RegAff believes that having marketing approvals for Pharma compounds and devices in Singapore is a ‘springboard’ to approvals in many countries in Asia.
One advantage RegAff can offer is the use of the ASEAN mutual recognition procedure as it relates to Cosmetics (safety, quality and claimed benefits) by first registering in Singapore. Increasing examples of recognition are in GMP inspections, information sharing and product alerts.
Europe
Full regulatory service
- Consultancy, strategic development
- Operationally regulatory support in house or remotely
- National and EMEA Scientific Advice
- Clinical Trials Applications and maintenance
- Dossier creation and e publishing
- License Maintenance
- POM to P switches
- Local Agent legal status (UK)
- SME status
- Country base staff (UK) and alliances
Dmitry Dmitriev,
MD, PhD, DSc of Raifarm LLC a leading professional service provider based in Moscow and an Alliance Partner with RegAff.
Debbie Scholey, PhD, FTOPRA
25 years of regulatory affairs experience leading Regulatory Affairs groups in both small and medium sized companies.
debbie.scholey@regaff.com
Tel: + 44(0)7768445083 RegAff Ltd (UK registered company and SME registered with EMA)
Tel: +44(0)1618706224
North America
- Consultancy advice to financial/legal companies
- Regulatory strategy/issues consultancy
- Use of ex-FDA Divisional Director level and senior ex-Pharma RA Industry
- Biologicals
- IS/IT experience and capability (e CTD and document management)
Sue Fekete, BSc (biology)
In-depth knowledge of the Biotech and Pharmaceutical business including Drug Development, Production and Commercialization, Promotional (Rx and DTC) and External Communication Strategies. Over 20 years regulatory experience in the industry with major biological, pharmaceutical and biotech companies in both North America and Europe.
sue.fekete@regaff.com
Karen Feltmate, BSc (biology)
30 years plus in Canadian Innovative Industry, 20 of these as Executive Team Member and strategic advisor. Delivered regulatory strategies for many new products and brought mutually beneficial partnerships together. Founder member of the Canadian Association of Pharmaceutical Regulatory Affairs group (formerly TRADG), has been a Board Member of the Canadian Pharmaceutical Distribution Network (CPDN) and the University of Toronto Mississauga Board for the Biotechnology Bridging Program. She has been a long standing member of Rx&D, the Research Based Pharmaceutical Industry organization.
George Butler, PhD
Regulatory Affairs leader in the Pharma Industry and has led Global Regulatory Affairs groups, most recently AstraZeneca and Novartis.
RegAff, Inc.
21 Tomney Rd,
Greenwich, CT 06830
george.butler@regaff.com
Tel: +1 203 622 1760 (or) Cell: 302 363 0818’
Latin America
Full regulatory service focused on Argentina, Brazil, Mexico and Venezuela.
- Included is an authorized Portuguese and Spanish translation service.
Susana Brea, MD
Susana Brea, MD worked in Big Pharma in Argentina for 30 years with responsibilities including regulatory affairs, clinical research, medical advisor and marketing product support.
Susana.brea@regaff.com
Tel: +54 911 40537425 international; 15 40537425 Argentina local
Middle East
Ilona Putz BSc (project management)
German born but Arabic oral and written communication skills; 12 years plus experience in regulatory affairs and medical information in PHARMA (MSD, SKB, Engelhard AG, Hexal AG, and Sandoz); Industry leader in ME regulatory.
ilona.putz@regaff.com
