Our Affiliates

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

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

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

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.

• GMP/QSR/GLP/GCP compliance consultation and gap analyses

• Audits and mock inspections

• Development of 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

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/

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

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.

» www.learningplus.com

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/

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

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

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.

» www.qpsupport.se

SARL Laban Consultants
Mr Frédéric Laban have been working as consultant and instructor/trainer for over 20 years in the areas of contamination control and Good Manufacturing Practice in the Pharmaceutical industry.

flaban13@gmail.com

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.

» www.seerpharma.co.uk

SUPERA QUALITY provides comprehensive consulting services for establishment, maintenance and improvement of quality management system and Good Manufacturing Practice (GMP) for pharmaceutical industry.
SUPERA QUALITY organizes and provides residential and in-house interactive GMP fundamentals training.
SUPERA QUALITY provides GMP audits for different purpose (contract manufacturer or supplier qualifications, due diligence, etc).
» www.supera-kvaliteta.com

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).

»www.tqab.se

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