Michael Anisfeld

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 Read more

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 and Asia.

Mr. Anisfeld has established and directed Quality Control, Quality Assurance, Production, Development, Materials Management and Supply Chain functions in the healthcare manufacturing/testing industry, and has instituted innovative, cost-effective auditing programs for his clients, ensuring they pass regulatory inspections first time.

Performing over 25 full scale mock inspections annually (to United States FDA, British MHRA, Canadian HPFBI, Australian TGA, and ISO 9001 standards), including audits whose reports are evaluated directly by national regulatory agencies as part of their product approval process, Mr. Anisfeld has served on both sides of the fence: Inspector and Inspectee – for 8 years acting as an inspector for the Australian TGA for companies located in the United States.

With over forty-five year’s expertise in the healthcare industry, he has held senior management positions in International Technology Transfer, Quality Assurance and Production and in the course of his career, he has designed pharmaceutical, medical device and active pharmaceutical ingredient (API) facilities in seven countries. A member of the adjunct faculty of the University of Illinois, where he lectures in Pharmaceutical Technology and Drug Quality issues, Mr. Anisfeld holds higher degrees in Pharmaceutical Technology (M.Sc.), Business Administration (MBA), Management (MSM) and holds a Diploma in Middle Eastern Studies (DMES).

An active member of many European and American regulatory and technical associations, he has served on the Board of Directors of the Parenteral Drug Association, and been Chairman of its Quality Control and Aseptic Processing Task Groups. An acclaimed international lecturer on the subject of GMP and Quality topics, Mr. Anisfeld is also a prolific author on these topics. He is the editor/author of many books on the subject including: "International Drug GMPs", “International Device GMPs”, “Keyword Guide to 21CFR”, “Guide to FDA International Inspections”, "Sterile Pharmaceutical Manufacturing", and PDA's monograph "Validation of Aseptic Processing of Liquid Drug Products", and “International Comparative Pharmacopoeia”. He is currently President of the Industrial Pharmacy Section of the I

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%

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)

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)