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Client Listing

 

 

Globepharm Consulting (formerly Interpharm Consulting) has worked with companies from the largest (Aventis, BASF, GlaxoSmithKline, Merck, Pfizer, Shionogi) to the “yet to be born companies” when venture capitalists ask us to evaluate prospective investments.

Inspections have been undertaken for United Nations agencies, national governments, and for private industry - and we can assist you, providing many benefits for outsourcing your audits or by establishing a strategic partnership.

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Agencies and Government
Industrial Clients and Attorneys

 

 

Agencies and Government

 

 

 

CLIENT

SPECIALTY

PROJECT DESCRIPTION

UNFPA Population Activities

Pharmacal
Devices
Chemical

GMP compliance auditing (Cuba)
GMP compliance auditing (China)
Facilities Planning (Vietnam)

US Food & Drug Administration

Government

Provide expert testimony for FDA during Government actions against manufacturer sued for GMP violations;
Taught FDA inspectors on 'how to inspect' and 'what to look for during drug facility inspection'

United States Congress

Government

Provided expert testimony to General Accounting Office regarding impact of regulations on innovation in the healthcare manufacturing industry

Therapeutic Goods Administration (TGA);
Australia

Government

Perform GMP audits in the USA on behalf of TGA,
for TGA to make final decision regarding GMP compliance and importation

Ministry of Health;
China (PRC)

Government

Training senior inspectors of the national inspection force on how to audit vaccine and blood product facilities for GMP compliance and quality improvement

Indian Government
All-India Institute of Technology; India

Government

Training senior scientists in GMP and Quality Technology to help establish national standards for medical devices

Ministry of Health;
Israel

Government

Assessment of world-wide GMP regulations, and recommendations

National Agency for Food and Drug Administration and Control (NAFDAC); Nigeria

Government

Training for NAFDAC inspectors in GMPs and how to effectively perform GMP inspections

Drug Regulatory Agency;
Sri Lanka

Government

Training for DRA inspectors in GMPs and how to effectively perform GMP inspections

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Industrial Clients and Attorneys

CLIENT

SPECIALTY

PROJECT DESCRIPTION

3M Pharmaceuticals;
USA

Pharmacal

Audit for GMP Compliance

3M Healthcare;
USA

Diagnostics

GMP compliance auditing, facility design concepts critique (radiopharmaceuticals)

3M Healthcare;
Mexico

Devices

GMP compliance auditing

Abbott Laboratories;
USA

Pharmacal

Project Confidential

Accucaps;
Canada

Pharmacal

FDA readiness assessment

Actavis;
Iceland

Pharmacal

“Due diligence” audits for potential acquisition candidate companies world-wide

Agis Pharmaceuticals;
Israel

Pharmacal

GMP critiques and improvements to facility design

AL Pharma;
USA

Pharmacal

GMP/GLP training for R+D professional staff.
Audit of R+D operations

Alberto-Culver;
USA

Cosmetics

Assessment of GMP Compliance to world-wide cosmetic GMP standards

Alcon;
USA

Pharmacal

Audit of manufacture of clinical supplies devices for US+European GMP compliance

Allied Warehousing;
USA

Bulk Repackager

GMP assessment for bulk API distributor

American Pharmaceutical Partners;
USA

Pharmacal

Audit for FDA Readiness;
GMP training;
Supplier and contractor GMP compliance assessments (China, Italy)

Amoli;
India

Chemical

Operations assessment to US cGMP regulations

Amway;
USA

Pharmacal

Australian GMP readiness assessment

Antisense Pharma;
Germany

Pharmacal

Audit of potential Canadian, US and European clinical manufacturing sites for Phase II and III clinical trials

Apotex/Apo-Biotics;
Canada

Pharmacal

pre-NDA and GMP Compliance auditing for FDA approval

Appolon;
USA

Pharmacal

FDA readiness assessment

Artemis;
India

Chemical

Gap analysis for compliance with US and EU GMPs

Automated Liquid Packaging;
USA

Pharmacal

GMP compliance auditing for manufacturer of plastic blow-and-fill sterile products

Astra-Zeneca;
United Kingdom

Chemical/

Facilities/Systems Audits prior to FDA Pharmacal inspections; GMP and FDA training

Avecia;
USA

Biotech

Facility design critique and FDA Readiness programs

BBC Radio;
United Kingdom

Miscellany

Assistance with preparation of, and interviewed for, BBC Radio program concerning counterfeit drugs

Beximco Pharmaceuticals;
Bangladesh

Pharmacal

Facility Design and GMP Upgrade Critique

Bioenergy;
USA

Nutraceutical

GMP guidance

Biotechnology General;
Israel, USA

Biotech

Facility and Process audits for GMP compliance. Capability and GMP audits

Boehringer Ingelheim;
France, USA

Pharmacal

Critique of company's Quality Systems; Facility design critique

British Biotechnology;
United Kingdom

Biotech

Audit of company's Quality Systems. 
In-House training, Supplier Audits

Bristol, Myers, Squibb;
USA

Pharmacal

In-House Training programs

Bushu Seiyaku;
Japan

Pharmacal

FDA Readiness Programs

Byk;
Nederland

Pharmacal

Mock FDA Pre-NDA Approval Inspection

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ChemAgis;
Israel

Chemical

Facility Design, GMP and Process improvement critiques during new facility planning. Product sourcing support. Regulatory agent with US-FDA; FDA readiness inspections

Chiroscience;
United Kingdom

Biotechnology

API supplier audit

Clay Park Laboratories;
USA

Pharmacal

Facility design and operational GMP  assessments; raw material supplier audits; Recovery strategies from FDA Warning Letter.

Clifford, Chance;
United Kingdom

Attorney

Provide expert GMP testimony

Colgate-Palmolive;
USA

Pharmacal

Management GMP Training

Croda;
United Kingdom

Chemical

GMP+FDA readiness training

Diatide;
USA

Biotechnology

Audit of Contract Supplier Sites

Dabur Oncology;
United Kingdom

Pharmacal

Assessment of clinical trial manufacturing facilities for FDA/GMP compliance

Desano;
China (PRC)

Chemical

Facility design critique, audit for GMP compliance, US regulatory agent with FDA

Ee-Wha;
Korea

Engineering

Review of design/built facility biotechnology facility to assure compliance with US cGMP requirements; GMP training for design engineers

Eisai;
Japan

Pharmacal/ Chemical

Assistance with facility design planning and design critique. GMP guidance for standards required to meet US-FDA and UK-MCA requirements

Enzymatix;
United Kingdom

Biotechnology

Facility design critique and agent with US-FDA for Drug Master Files

Erregierre;
Italy

Chemical

Audit for GMP compliance

Faulding;
Australia

Pharmacal

GMP Compliance Assessment, Training

Ferro-Pfanstiehl Laboratories;
USA

Chemical

Assistance with GMP compliance, DMF preparation, and GMP training. Preparation of validation master plans and protocols; FDA readiness assessment

Fertin;
Denmark

Pharmacal

Assessment of GMP compliance for new dosage delivery system

CB Fleet;
Spain, Sweden, USA

Cosmetics

Assessment of GMP Compliance to world-wide cosmetic GMP standards; Training

Fournier;
France

Pharmacal

Review of new facility design for compliance to FDA requirements. Provision of validation protocols and standard procedures

Fujisawa Healthcare;
USA

Pharmacal

GMP Training

Gedeon Richter;
Hungary

Chemical/ Pharmacal

Facilities+Operations: Review for evaluation as to meeting US GMP requirements. Mock-FDA PreApproval Inspections

Genzyme;
Belgium

Pharmacal

In-House Training

GlaxoSmithKline;
Australia, Singapore, India, United Kingdom, Canada, France, Italy, USA

Pharmacal/
Chemical

Review of R+D and manufacturing facilities for GMP compliance prior to FDA inspection, including computer systems; GMP Training

GW Pharma;
United Kingdom

Pharmacal

Assessment of Quality systems; Training

Hedlund, Hanley and John;
USA

Attorney

“Expert Testimony” on GMP matter

IBI Farma;
Italy

Chemical

FDA Readiness Assistance for manufacturer of bulk antibiotics

IPC;
Jordan

Pharmaceutical

Assistance with GMP matters

J+J /Ethicon;
USA

Devices

Audit for GMP compliance; GMP training

J+J/Janssen;
Ireland

Pharmaceutical

In-House Training

Kamada;
Israel

Blood Products

Assessment of FDA readiness

Keller + Hechtman;
USA

Attorney

Emergency Resolution of Client GMP Compliance Issues with FDA

Lek (part of Sandoz-Novartis);
Slovenia

Pharmacal

Mock-FDA Pre-Approval Inspection (PAI) of product development laboratories and solid dose manufacturing operations; evaluation of compliance to electronic records (21CFR11)

Ludan Engineering;
Israel

Contractor

Training design and construction engineers in GMP requirements

Luxembourg Pharma;
Israel

Pharmacal

“Due Diligence” GMP inspections of potential acquisition candidates

Eli Lilly;
United Kingdom

Pharmacal

Mock-FDA Pre-Approval Inspection (PAI) of development laboratories and clinical trial manufacturing operations

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Mallinckrodt;
USA

Devices/
Chemical

Assessment for GMP compliance; Training

Mallinckrodt Veterinary;
New Zealand

Pharmacal (Vet)

Assessment for US-GMP Compliance

Marion Merrell Dow;
USA

Pharmacal

Assistance with preparing for FDA inspection of new manufacturing facility. Perform mock-FDA audit

MacFarlan + Smith;
United Kingdom

Chemical

Validation support and Mock-FDA readiness inspection.

Manhattan Drug Company;
USA

Nutraceutical

Audit for compliance to Australian GMPs

Merck and Company;
USA

Pharmacal

Consulting on Validation Issues;
GMP Training

National Nutritional Laboratories;
USA

Nutraceutical

Audit for compliance to Malaysian GMPs

Nerapharm;
Czech Republic

Chemical

Recovery plans from FDA Warning Letter FDA readiness assessment

Nestle;
USA

Pharmacal

Project Confidential

Nucro-Technics;
Canada

Testing Lab

GMP Training

Nutrilite (Amway);
USA

Pharmacal

GMP Audit of US manufacturer of OTC drugs for compliance to Australian GMPs

Organon;
Netherlands

Pharmacal

In-House GMP/Quality Training Courses

Organon Teknika;
USA

Biotech

GMP audit for US manufacturer of vaccine prior to UK-MCA inspection

Pangeo Pharma;
Canada

Pharmacal

FDA readiness assessment

Pascual Labs;
Philippines

Pharmacal

Assess level of GMP compliance to world standards

Perio;
Israel

Pharmacal

Facility/Process review for GMP compliance to meet FDA requirements

Pfizer;
United Kingdom

Pharmacal

In-House Training

Pharmacia;
USA

Chemical/
Pharmacal

FDA readiness assessment;
GMP Training

Pharmagis;
Israel

Pharmacal

New facility GMP design critique. Audits for US GMP compliance

Pliva-Lachema;
Czech Republic

Pharmacal

GMP compliance assessment; training

Procter+Gamble;
France, Germany, USA

Pharmacal

Confidential Projects, and GMP Training

Quadra Logic;
Canada

Biotech

In-House GLP/GMP training courses for R+D scientists

Rhodia;
USA

Pharmacal

Audit of API manufacturers

Robins, Kaplan;
USA

Attorney

Court Testimony in case involving GMP issues

Roquette;
France

Chemical

Recovery Strategy from FDA Warning Letter

Sage Products;
USA

Devices

GMP Compliance Advice

Sauflon;
United Kingdom

Pharmacal

Assessment of compliance to US cGMPs

Scandipharm;
USA

Pharmacal

Audit of contract manufacturer

RP Scherer;
USA

Pharmacal

Australian TGA GMP Compliance Audit

RP Scherer;
France, Germany

Pharmacal

QA Systems implementation assistance

RP Scherer;
United Kingdom

Pharmacal

Pre-NDA/GMP compliance audit prior to FDA inspection; review of quality (QA/QC activities and organization

Scotia Pharmaceuticals;
United Kingdom

Pharmacal

FDA readiness assessment

Shionogi;
Japan

Chemical/
Pharmacal

Facilities and equipment design/operations critique prior to anticipated Japanese government (MHW/PAB) inspection

Slovakopharma;
Slovakia

Pharmacal

GMP compliance assessment to US GMPs

SmithKline Beecham;
Singapore

Chemical/
Pharmacal

In-house GMP training for senior and middle management

Smith+Nephew;
United Kingdom

Devices

Audit for compliance to FDA GMPs

Smith+Nephew;
USA

Devices

Audit for compliance to Australian GMPs

Spencer, Fane;
USA

Attorneys

GMP testimony
– matter sub judice

Solgar Vitamin;
USA

Nutraceutical

Australian TGA GMP Compliance Audit

Streck Labs;
USA

Diagnostic

Assessment of compliance to electronic record requirements (21CFR11); training

TUV;
Korea

Standards

GMP training for ISO 9000 inspectors

Unilever,
India, Philippines, Mexico

Pharmacal

FDA readiness assessment; VMP and QA Systems implementation

Unither;
USA

Pharmacal

FDA readiness assessment of contract manufacturer and test labs

Valois Pharm;
France

Supplier

Audit for GMP compliance of manufacturer of critical primary/immediate packaging

Warner-Lambert;
USA

Pharmacal

Product Batch Certification
(part of Company/FDA consent decree)
GMP Compliance Auditing

Warner-Lambert;
Ireland

Biological

GMP audit prior to an FDA Establishment License Application (ELA) / Biological Product Application (BLA) inspection

Wechsler Skirnick;
USA

Attorney

Provide expert testimony in litigation

Yamanouchi;
Ireland, Italy, Netherlands

Pharmacal

FDA readiness assessment; GMP Training

 

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