We provide knowledge and information about CGMP and Quality Systems to the Health Care industry

GMP translations (FR, IT, SE, DK)

KEY2GMP®

Search tool and document library. Find you way in regulations, guides and other reference documents.

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About us

Our mission and our activities

"We provide knowledge and information about CGMP
and Quality Systems to the Health Care industry"

Training and Seminars

Continuous GMP training is required by the authorities, and is also an important tool to enhance the GMP compliance level. We develop and arrange open courses and in-house training programs in local languages and also arranges international courses, seminars and conferences.

Literature

We produce literature and GMP booklets in pocket size format for both US and EU GMP's.

» The GMP Handbook (English, French, Swedish)

» GMP's in American/Engish

» French translations (US GMP's 21CFR 210/211 and 820)

» Swedish translations (US and EU GMP's )

» Danish translations (EU GMP's )

KEY2GMP® On-Line GMP documentation search tool

Unique application based on Mr. John Y. Lee's course "CGMP Interpretations and Applications". Saves time and supports you in auditing, FDA disputes and your daily GMP issues.
» Learn More

One Trademark and two Companies

Key2Compliance®

Is our common Trademark for the GMP training concept of our 2 companies.
The training programs offered within the Key2Compliance® training network are carefully selected to fulfil CGMP training and education needs in specific areas. The main objective of our training programs is practical and current applications. We fulfil this objective by recruiting and assigning instructors who are recognised experts in their field of interest, with hands-on practical industry experience and/or regulatory experience.

Lundén/Ellow ab

Lundén/Ellow ab was founded 1995 in Stockholm, Sweden, to offer the pharmaceutical industry in Sweden and in neighbouring countries technical consultation and training. In 1996 collaboration started with Mr. John Y. Lee, Pharmaceutical Compliance Associates in N.Y. (US), which led to an expansion of activities and also a diversion towards international GMP courses. Today we collaborate with Mr. John Y. Lee and several other international well known and acknowledged professionals. Services offered to the pharmaceutical, biopharmaceutical and medical device industry by Lundén/Ellow:

International Compliance Seminars® in various European cities.
In-house training courses at various plants in Europe with our international instructors.
Interfacing between industry and international consultants (consultation and auditing)
Developing and conducting GMP courses in Swedish, for all level of personnel.
Organising International GMP Compliance Conferences in collaboration with our affiliates.

EuroGMP AB

EuroGMP® is a joint venture company between Lundén/Ellow ab and Mr. John Y. Lee. The company's objective is to create a European GMP training network where we can offer on-site CGMP training in local languages. The existing training program is based on basic modules for operators and technicians, but a variety of customized modules are also available. Know-how and updated material is provided by Mr. John Y. Lee (former FDA investigator), and supervised by Ms. Anna Lundén (training manger Lundén/Ellow ab). With EuroGMP® we will establish our concept in major European countries such as English, French, Italian, German and Spanish speaking regions.
EuroGMP® is also developing and distributing KEY2GMP™, the On-Line Search tool for regulations and interpratations