"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"

Our Affiliates

We are proud to present the companies and organisations we are working with in different training and consultant projects. Click the name in the right column for information and links.

We are searching for more affiliates to expand our network

Have you got skills, ideas and knowledge to share?

To be able to keep our top position as one of Europe’s leading Compliance training and consultancy organizations we are constantly looking for new ideas, topics, and partners.
So if you got something special to offer we are always interested to listen.

The partnership can be for one or several of our business:
  - Skilled trainers/instructors for our GxP course programs in local languages.
  - Instructors for our international course program, Compliance Seminars®.
  - Marketing/selling our books and games locally and translations to local languages.

Contact us »

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


ACE 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


Blue Bell Consulting

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/QS/GLP/GCP compliance consultation and gap analyses
  • Audits and mock inspections
  • Development of practical GMP/QS/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


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/


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


e@syGMP

e@syGMP Prestations / Services
FORMATION : transformer les contraintes en outils
AUDIT ET CONSEIL : développer l'expertise des interlocuteurs
PREPARATION A L'INSPECTION / INSPECTION PREPARATION : maîtriser l'événement
PUBLICATIONS : Améliorer ses connaissances
» www.easygmp.com


Enjoy The Gap

Egrelius Quality Consulting AB erbjuder kvalitetsledning med fokus i läkemedels- och medicintekniska branschen - uppstart, utveckling, förvaltning
» www.egrelius-quality.se/


Enjoy The Gap

Enjoy The Gap erbjuder konsultstöd och utbildning inom följande områden:
• Utbildningsproduktion - Utveckling av företagsinterna utbildningar
• Strategisk kompetensutveckling
• Gruppträning - Behovsanpassat teamlärande
» enjoythegap.se


Genau & More

Genau & More provides a comprehensive range of compliance services for life sciences aimed to advance quality in patient care and safety. Genau & More specializes in project management, GAP analysis, validation and change management thus providing both senior experience as well as hands-on execution of projects based on accurate regulatory interpretations. Genau & More services provide clients with a distinct competitive advantage based on long-term inspection readiness, fast time to market and significantly reduced costs.
» www.genauandmore.com


J Karling Consulting

Johanna Karling is an independent consultant providing consultancy in Quality Assurance and Regulatory Affairs-related issues to Medical Device / Life Science companies in a start-up phase and expansion phase. Johanna have long experience of strategic QA and global Regulatory Affairs in an international environment for large and small Med Tech companies.
» J Karling Consulting at LinkedIn


LearningPlus logo

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


MedIQ Consulting logo

MedIQ Consulting AB har mer än 18 års erfarenhet av GMP (Good Manufacturing Practice) och validering inom läkemedelsvärlden. MedIQ Consulting AB åtar sig kortare och längre uppdrag inom bland annat projektledning, kvalitetsstrategier och validering.
» www.mediqconsulting.se/


Nishiyama Consulting office

Nishiyama Consulting office is a Japanese Registered Management Consultant and the Japanese sales outlet for Gate2GMP®. We also provide Japanese versions of PharmaNet GMP training Courses and quality management consultation specially focused in the Pharmacetutical and Medical Device areas.
» http://ncogmp.com


PathWice Inc.

In a globally regulated life science industry, PathWise provides proven methodologies in quality and compliance through hands-on, practical solutions that ensure compliant, effective, and efficient quality systems. We partner with life science manufacturers to ensure quality, safety and compliance in our worlds healthcare. Since 1993, we’ve worked with the best in the life science and manufacturing industries and bring an intimate knowledge of regulatory and compliance standards.
» www.pathwise.com


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


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


QP Support AB

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 investigationalmedicinal 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


rightQA.dk logo

rightQA.dk is a consulting company focused on helping pharma and biotech com-panies with quality processes, as well as the development process. We can also assist in organization and re-organization of the Quality area. Behind rightQA.dk is Hasse Herlevsen with more than 30 years’ experi-ence in the industry, including big pharma, mid-size pharma, small bio-tech and medical devices. With this experience, rightQA.dk can give you good consulting and practical solutions - e.g. audits, inspections, due diligences and quality advice. Also developing quality agreements and other documents. Improvement of quality systems and IT systems.
» www.rightQA.dk


SeerPharma logo

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 Kvaliteta logo

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


Symbioteq

Symbioteq erbjuder medicintekniska och vårdgivande organisationer tjänster inom affärsutveckling, kvalitetssäkring och regulatorisk support som leder till bättre affärer.
» www.symbioteq.com


TQ Logo

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


WeGa Analys Logo

WeGa Analys erbjuder konsulttjänster inom områdena Good Manufacturing Practice (GMP) och Good Distribution Practice (GDP) för läkemedel och prövningsläkemedel inom FoU, produktion, kvalitetskontroll och kvalitetssäkring.
WeGa Analys kan hjälpa er att:

  • Utveckla/revidera kvalitetssystem och instruktioner inom utveckling, produktion, kvalitetskontroll och kvalitetssäkring
  • Som certifierad Lead Auditor utföra inspektioner inom läkemedelsområdet inklusive hela ”supply chain”, både i Sverige och utomlands
  • Ge svar på vilka krav som gäller enligt aktuella regelverk i en specifik fråga
  • Löpande bevaka nyheter i regelverken inom ett specifikt område t ex aktiva susbstanser, kliniska prövningar
  • Utföra riskanalys vid bedömning av leverantör av råvara eller tjänst, i syfte att kunna avgöra om en inspektion är nödvändig i kvalificeringsprocessen av leverantören
» wegaanalys.se