QA-TI Quality Assurance & Technical Intelligence

QA-TI   Quality Assurance & Technical Intelligence QA-TI Quality Assurance & Technical Intelligence - adviser bureau
working on the fields of the ph

QA-Ti was founded on the basis of 38 years of experience in the pharmaceutical industry. Based on proven and sound knowledge gained during the leading/participating of a huge number of projects we can offer a wide range of services on quality assurance and pharmaceutical engineering fields.

Find our office:
20/11/2017

Find our office:

09/10/2017
09/10/2017
QA-TI Quality Assurance & Technical Intelligence added a new photo to the album: Speed review — at  -TI adviser bureau, ...
09/10/2017

QA-TI Quality Assurance & Technical Intelligence added a new photo to the album: Speed review — at -TI adviser bureau, Leiden, NL.
43 mins ·
Our famous doc review ACTION!!! is coming back for the vacation!
Apply, send your documents and enjoy your vacation!
-TI

Our famous doc review ACTION!!! is coming back for the vacation! Apply, send your documents and enjoy your vacation! -TI...
09/10/2017

Our famous doc review ACTION!!! is coming back for the vacation!
Apply, send your documents and enjoy your vacation!
-TI

Proudly, we share with you our new work reference written by Laszlo RethelyiHead of Corporate Project Management Office ...
22/05/2016

Proudly, we share with you our new work reference written by Laszlo Rethelyi
Head of Corporate Project Management Office at EGIS Pharmaceuticals PLC
He wrote about the services QA-TI provided:

"The building up of the new R&D Center for HP API & DP development (building-3 project) and the enlargement of the Scale-up facility (building-7 project) (with value of 6.5 mill Eur) were supported by EU and governmental founds and aimed to be finished for the centennial establishment celebrations of EGIS. Katalin was responsible for the GMP compliance of the new facilities, in general, with emphasis on building-3. She fulfilled the following tasks in the project team: - participation in the selection of the suppliers of the isolators, establishing URS-s, qualification of designs, - review and comment on the different plans/drawings of engineering disciplines in relation to the construction of the building, communicating GMP requirements, establishing URS-s, - performing weekly tours of the facility, commenting / supporting ongoing works from QA point of view, - review and approval of all IQ / OQ, qualification / verification / validation protocols and reports related to the new equipment / new systems / new facility,. Katalin proactively initiated four important, quality enhancing changes during the design qualification and the construction - with good time keeping. The project was successfully closed within the predefined 18 months time-frame. The NIP approved the use of the new building for the planned R&D activities without critical or major observations. She was a very active and invaluable asset of our operative team. During her work with different departments of our directorate she showed her cross-functional communication skills and high level interdisciplinary knowledge on diverse fields of engineering. She presented the quality objectives on a creditable manner - with the eyes of the engineers. We appreciated her constructive initiations, which were helping us to deliver our project on time and in high quality. "

11/03/2016

Services we are providing:
- Quality Assurance & Technology Transfer advises for the Pharma Industry;
- Quality Assurance consultancy for pharmaceutical R&D;
- Advises / review of CMC dossiers, submission files, technology development protocols and reports, analytical method development protocols / reports;
- Advises in special investigations, assignment and handling of CAPA activities;
- Supplier qualification / CRO management, GxP / ISO audits

Adres

Wilhelmina Bladergroenweg 26
Leiden
2331BX

Openingstijden

Maandag 00:00 - 17:00
Dinsdag 10:00 - 18:00
Woensdag 10:00 - 18:00
Donderdag 10:00 - 18:00
Vrijdag 10:00 - 17:00

Telefoon

+31619991227

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Our Story

QA-Ti was founded on the basis of 38 years of experience in the pharmaceutical industry. Based on proven and sound knowledge gained during the leading/participating of a huge number of projects we can offer a wide range of services on quality assurance and pharmaceutical engineering fields. We provide ‘Clear Solution’ to our customers on the fields of - Compliance management of new facilities - Validation / Qualification works - Compliance review of cGMP documents Our portfolio also available on LinkedIn https://www.linkedin.com/company/10558819 #QA-TI #pharmaadvice #pharmaconsult


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