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 |
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 |
| |
|
|
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 |
| |
|
|
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 |
