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Our Affiliates

We are proud to present the companies we are working
with in different training and consultant projects.
Click the company name below to see full info.

China
» Blue Bell Consulting

Danmark
» KBJ Pharma

Deutchland
» CS2 - Clinical Supplies Consulting Services

France
» ACE Performance Cabinet

Italia
» Quality Systems (EuroGMP® representative)

Japan
» Nishiyama Consulting Office

Slovenia
» BE-i Institute

Sverige
» SIS Forum

USA
» AAMI
» Bernstein CMC Regulatory Consulting
» ComplianceNet
» Pharmaceutical Compliance Associates
» PharmaNet

GMP Booklets

KEY2GMP™

GMP Quiz

PharmaNet, Inc PharmaNet - Leaders in GMP Compliance Training.
Education programs offered by PharmaNet have been carefully selected to fulfill training and education needs in specific areas. Program selection and contents are usually determined based on industry surveys which show that no similar programs, or programs with the same quality level, are being offered by other industry organizations. The objective of our educational programs is practical and current application.
» www.gmpseminars.com
Pharmaceutical Compliance Associates Pharmaceutical Compliance Associates Pharmaceutical Compliance Associates (PCA) specializes in compliance consultation relating to current Good Manufacturing Practice (GMP) regulations and Food & Drug Administration (FDA) requirements. Services offered by PCA include compliance audits and mock FDA inspections, establishment and implementation of quality assurance programs, development and review of validation studies, investigation and resolution of compliance and quality problems, compliance review of facilities and equipment design, and development and presentation of employee training programs. PCA's consultation and training services are conducted by professionals with extensive compliance experience including prior employment with the FDA.
» www.gmpseminars.com/PCA/index.htm
AAMI AAMI The Association for the Advancement of Medical Instrumentation (AAMI), founded in 1967, is a unique alliance of over 6,000 members united by the common goal of increasing the understanding and beneficial use of medical instrumentation.
» www.aami.org

SIS Forum SIS Forum
SIS Forum erbjuder utbildningar och konsulttjänster som gör det lättare och lönsammare att tillämpa standarder. Genom vår kunskap om standarders möjligheter kan vi hjälpa våra kunder att skapa verklig nytta och lönsamhet i sina verksamheter.
I SIS Forums utbildningsverksamhet erbjuds ett brett sortiment av utbildningar inom bland annat verksamhetsutveckling (ISO 9000 & ISO 14000), CE-märkning, EG-direktiv, industriteknik och medicinsk teknik. Men vi erbjuder också utbildningar inom alla standardiseringsområden när det finns nyheter och intresse. SIS Forums konsulttjänster täcker in samma områden som utbildningarna.
 SIS Forum är ett helägt dotterbolag till SIS, Swedish Standards Institute.
» www.sis.se
ComplianceNet, Inc ComplianceNet ComplianceNet, Inc. provides a wide variety of services to help your company meet international regulatory challenges. We specialize in helping small, start up firms establish efficient, cost effective quality systems that will pass inspection and produce high quality products. We help firms match their level of Regulatory Compliance with their stage in the Drug Development Process - Pre-Clinical, Phase I through Phase III, up to and including Market Product.
» www.gmpcompliance.net
QUALITY SYSTEMS S.r.l Quality Systems (Italia) QUALITY SYSTEMS S.r.l. offre alle aziende farmaceutiche, chimico-farmaceutiche e cosmetiche italiane consulenza tecnica e corsi di formazione e aggiornamento nell’ambito della “GMP Compliance” e ISO 9000 Il personale altamente qualificato che si occupa della consulenza e della formazione dispone di una significativa esperienza nell’ambito della Quality Assurance e della Produzione.
» www.qualitysystems.it
CS2 - Clinical Supplies Consulting Services CS2 - Clinical Supplies Consulting Services Clinical Supplies Consulting Services is a professional services firm specialised in providing management consulting services to the pharmaceutical industry in the area of investigational medicinal products (IMPs) and related topics within the entire pharmaceutical development process chain.

» www.cs2-pharma.de/

Bernstein CMC Bernstein CMC Regulatory Consulting provides comprehensive regulatory compliance and pharmaceutical sciences development services to the pharmaceutical and biotech industry. We provide a full range of coordinated regulatory and technical services including conceptualization, definition and implementation of CMC development programs incorporating strategic planning and integration of CMC development plans with toxicology and clinical development requirements. We also prepare and/or review regulatory submissions (IND, NDA, CTA), conduct GXP compliance audits and manage and provide liaison with CMC contractors as a member of your project team.
» www.bernsteincmc.com
ACE Performance CabinetACE Performance Cabinet ACE Performance Cabinet answers to your specific requests or company expectations by developing activities exclusively focused on organizations, systems, resources, performance improvement. Therefore, ACE Performance fits to your requirements and offers:
• Life and Corporate coaching
• Specific trainings in continuous improvement, Quality

Management System, Lean manufacturing, process audit,
communication strategy.
• Consulting activities developed exclusively for your specific

requests in Quality, Continuous Improvement and
Performance beside coaching and trainings.
ACE Performance is the expertise of international companies with high level requirements in Quality, Strategy and Human Resources.
» www.ace-cabinet.fr
Nishiyama Consulting office Nishiyama Consulting office Nishiyama Consulting office is a Japanese Registered Management Consultant and the Japanese sales outlet for KEY2GMP(TM). We also provide Japanese versions of PharmaNet GMP training Courses and quality management consultation specially focused in the Pharmacetutical and Medical Device areas.
» http://homepage2.nifty.com/m_nishiyama/
BE-i Institute BE-i enhance pharmaceutical quality and the GMP compliance level in the pharmaceutical, biopharmaceutical and Medical Devices industry.
• The BE-i concept specializes in developing and implementing a QS (quality system), adapted to customer needs and training the staff for optimal compliance.
• BE-i works within a network of international experts, auditors and consultants.
• BE-i offer auditing, mock inspection and due diligence, including R/D
• BE-i provide expertise for developing innovation systems within pharma R/D
» www.be-i.org
KBJ Pharma KBJ Pharma KBJ Pharma is principally consulting the pharmaceutical industry in Quality Assurance, current legislation concerning control of medicinal products and in-house and postgraduate training in GMP. By using KBJ Pharma you receive updated knowledge, an extra resource person for a given period and a sparring partner for discussions of relevant topics. You decide the extent and length of the assistance and only pay for the services delivered.
» www.kbjpharma.dk
Blue Bell Consulting Blue Bell Consulting Blue Bell Consulting (BBC) is a premier regulatory consulting firm located in Shanghai, China, providing following world-class professional services for FDA-regulated industries worldwide, particularly in Asia.
• GMP/QSR/GLP/GCP compliance consultation and gap analyses
• Audits and mock inspections
• Developing practical GMP/QSR/GLP/GCP training courses and workshops
• Implementation of compliance programs
• Preparing and/or reviewing DMFs, INDs, ANDAs, NDAs, BLAs, 510(K)s, PMAs, and annual reports
» www.bluebell-consulting.com


Lundén/Ellow ab and EuroGMP AB • Tjädervägen 10 • SE-181 56 Lidingö • SWEDEN • Phone: +46-(0)8-544 811 60 • e-mail: info@key2compliance.com