The GMP board game that tests and improves your GMP compliance, knowledge, attitude and awareness!
The GMP Handbook for pharmaceuticals
Quality Systems Handbook for MedDev
E-books: US and EU regulations
GMP translations (FR, SE, DK)
Search tool and document library. Find your way in regulations, guides and other reference documents.
We are proud to present the companies we are working with in different training and consultant projects.
Click the company name in the right column to see info and the hyperlink to the company website.
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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.
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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:
ACE Performance is the expertise of international companies with high level requirements in Quality, Strategy and Human Resources.
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BE-i enhance pharmaceutical quality and the GMP compliance level in the pharmaceutical, biopharmaceutical and Medical Devices industry.
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Blue Bell Consulting (BBC) is a premier compliance and regulatory consulting firm based in Shanghai, China, providing following professional services for FDA-regulated industries worldwide, particularly in Asia.
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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.
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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.
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Since 1991, LearningPlus has created innovative instructional products for the pharmaceutical and health-care industries using video and computer technologies as more effective and efficient delivery media. Large and small companies throughout the world use their workshops, training courses, and consulting expertise.
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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.
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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.
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PharmaNet - Leaders in GMP Compliance Training.
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QP Support AB is a holder of a Manufacturing Authorisation which covers Release of medicinal products and investigational medicinal products manufactured within EU and release of medicinal products and investigational medicinal products in connection with import to EU.
QP Support AB offers services as: - Qualified Person and QP release of batches - Quality advisor regarding GMP - GMP-auditing of manufacturers and laboratories - Preparation for authority inspections (EU/FDA) - Updating and improvement of quality systems - Preparation and revision of documents, such as SOP, batch records for manufacturing and packaging.
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SARL Laban Consultants
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SeerPharma provides fully integrated solutions across QA, GxP compliance, training, risk management, validation, IT, productivity and quality management systems. The solutions service the entire product lifecycle, from pre-clinical to commercial manufacture. SeerPharma offer international quality management and cGMP experience and practical advice to support client’s compliance management and productivity improvement across the pharmaceutical, medical device and biological industries. |
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SUPERA QUALITY provides comprehensive consulting services for establishment, maintenance and improvement of quality management system and Good Manufacturing Practice (GMP) for pharmaceutical industry. |
TQ Kvalitetskonsult AB är ett konsultföretag som erbjuder tjänster som rådgivning och genomförande av GMP relaterade uppdrag för Biotech och traditionella läkemedelsföretag. Företaget genomför inspektioner av API tillverkare och läkemedelsföretag av både kliniskt prövningsmaterial och läkemedel inom och utanför EU. TQ Kvalitetskonsult AB kan också erbjuda tjänster som Sakkunnig Person (QP). |
» CS2 - Clinical Supplies Consulting Services
France
» AAMI (Medical Device)