Profile

Professional summary

I specialize in the working with companies, governments and attorneys to ensure that Good Manufacturing Practices are effectively and efficiently met. I have expertise in the GMP requirements of the US FDA, the European Union EMA-GMPs, and perform mock inspections for clients world-wide.

Michael H. Anisfeld is a senior consultant for Globepharm Consulting, Inc., specializing in GMP/Quality activities for governments and healthcare manufacturing industries. In his current position he numbers among his clients United Nations Agencies (WHO, UNFPA, UNIDO), national regulatory agencies (including the US-FDA, Australian TGA) and over 300 pharmaceutical, medical device, biotechnology and bulk pharmaceutical companies in the Americas, Africa, Europe

Engagement overview

Engagements are client specific.
If clients are willing to pre-pay for 20 days of work in a single year, then we reduce our rates by 20%

Clients

Government Clients:
• United Nations Fund for Population Activities (UNFPA)
• US Food & Drug Administration (US-FDA)
• US Agency for International Aid (USAID)
• Australia: Therapeutic Goods Administration (TGA)
• Bangladesh: Directorate General of Drug Administration (DGDA)
• Brazil: Agencia Nacional de Vigilancia Sanitaria (ANVISA)
• China: State Food and Drug Administration (CFDA)
• Cuba: Ministerio de Salud Publica (MinSaP)
• Ghana: Food and Drug Board (FDB)
• India: All-India Institute of Technology (AIIT)
• Israel: Ministry of Health (MOH)
• Mongolia: Specialized State Inspection Agency (SSIA)
• Namibia: Namibia Medicines Regulatory Council (NMRC)
• Nigeria: National Agency for Food and Drug Administration and Control (NAFDAC)
• South Africa: Medicines Control Council (MCC)
• Sri Lanka: Drug Regulatory Agency (DRA)

Litigation / Arbitration:
• US Department of Justice, USA (on behalf of FDA)
• Barsalou Lawson, Canada (on behalf of pharma company)
• Clifford Chance, United Kingdom (on behalf of pharma company)
• Freshfields, Germany (on behalf of pharma company)
• Hedlund, Hanley + John, USA (on behalf of pharma company)
• Kirkland Ellis, USA (on behalf of pharma company)
• Norton Rose, South Africa (on behalf of pharma company)
• Robins, Kaplan, et al, USA (on behalf of pharma company)
• Spencer, Fane, et. al, USA (on behalf of pharma company)

Companies:
• 3M Pharmaceuticals - USA
• 3M Healthcare – Mexico / USA
• Abbott Laboratories – USA
• Accucaps – Canada
• Actavis - Malta, Poland, USA
• AiCuris – USA
• Aptuit - India, USA
• Agis Pharmaceuticals – Israel
• AL Pharma – USA
• Alberto-Culver - USA
• Alcon – USA
• Allied Warehousing- USA
• Allos – USA
• AntiSense Pharma – Germany
• American Pharmaceutical Partners – USA
• Antisense Pharma – Germany
• Apotex/Apo-Biotics – Canada
• Appolon – USA
• Artemis – India
• Automated Liquid Packaging –USA
• Astra-Zeneca - United Kingdom
• Avecia - Scotland, USA
• Binex - Korea
• Bionomics – Australia
• Biotechnology General -Israel, USA
• Bioton- Poland
• Boehringer Ingelheim- France, USA
• Bristol, Myers, Squibb – USA
• Mitsubishi Tanabe - Australia, Japan, USA
• Cipla- India
• Clifford Chance - United Kingdom
• Dabur Oncology - India, United Kingdom
• Desano - China (PRC)
• Egis – Hungary
• Eisai –Japan
• Estee Lauder - Belgium, Canada, USA
• Fertin – Denmark
• Finetech – Israel
• CB Fleet - Spain, Sweden, UK, USA
• Fresenius-Biotech – Germany
• Freshfields – Germany
• Gedeon Richter - Hungary, Poland, Romania
• Gentium - Italy
.... and other companies (details and references available on request)

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Areas of expertise